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		<title>How to Ensure Your Soya Paneer and Paneer Are Properly Lab Tested for Quality, Safety &#038; Authenticity</title>
		<link>https://choksilab.in/how-to-ensure-your-soya-paneer-and-paneer-are-lab-tested-and-safe/</link>
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		<dc:creator><![CDATA[admin_choksi]]></dc:creator>
		<pubDate>Thu, 20 Aug 2026 03:56:43 +0000</pubDate>
				<category><![CDATA[Latest news]]></category>
		<guid isPermaLink="false">https://choksilab.in/?p=13860</guid>

					<description><![CDATA[<p>How to Ensure Your Soy Paneer &#38; Paneer Are Lab Tested and Safe Paneer and soy paneer are widely consumed food products, but ensuring their quality, authenticity, nutritional accuracy and safety is essential. Laboratory testing helps assess these products for adulteration, microbiological contamination, nutritional composition and chemical contaminants. With growing concerns around fake paneer, adulteration and product quality, professional laboratory testing can help manufacturers, retailers, HoReCa businesses, exporters and consumers make informed decisions about product safety and compliance. What Does Paneer Testing Cover? A comprehensive paneer testing program can include: Microbiological Testing Paneer contains high moisture and protein, making it highly perishable. Microbiological testing can assess parameters such as E. coli, Salmonella, Listeria, yeast and mold, and total plate count to evaluate product safety. Adulteration &#38; Fake Paneer Testing Testing can help identify common adulteration indicators such as starch, synthetic milk, urea, detergent residues, foreign fat and vegetable oil markers such as β-sitosterol. Nutritional Analysis Laboratory analysis can verify important nutritional parameters including protein, fat, moisture and carbohydrates, helping ensure that nutritional claims are supported by laboratory results. Chemical Contaminant Testing Depending on the testing requirement, laboratories can screen for heavy metals such as lead and arsenic, pesticide residues, preservative levels and antibiotic residues. Why Is Soy Paneer Testing Important? Soy paneer requires specific attention because it is a plant-based product with different quality and safety considerations compared with dairy paneer. A detailed soy paneer testing program may include: Since soy is a common allergen, appropriate testing and accurate declaration are important considerations for product labeling and consumer safety. Why Should Food Businesses Test Paneer? For manufacturers, retailers, HoReCa suppliers and exporters, regular laboratory testing can help reduce risks related to: Regulatory penalties • Product recalls • Brand damage • Legal liabilities • Customer complaints Testing also supports regulatory compliance, brand trust, export requirements and reduction of product-recall risks. Read the Complete Guide For detailed information on paneer and soy paneer testing, adulteration detection, food-safety parameters and laboratory testing considerations, download or view our complete guide below. Choksi Laboratories provides comprehensive analytical testing solutions to support food quality, safety, authenticity and regulatory compliance, helping businesses make informed decisions and maintain confidence in their products. Test. Verify. Trust. Reliable laboratory testing helps support food quality, product authenticity, consumer safety and regulatory compliance.</p>
<p>The post <a href="https://choksilab.in/how-to-ensure-your-soya-paneer-and-paneer-are-lab-tested-and-safe/">How to Ensure Your Soya Paneer and Paneer Are Properly Lab Tested for Quality, Safety & Authenticity</a> first appeared on <a href="https://choksilab.in">Choksi Laboratories</a>.</p>]]></description>
										<content:encoded><![CDATA[<figure class="wp-block-image aligncenter size-full is-resized"><img fetchpriority="high" decoding="async" width="1536" height="1024" src="https://choksilab.in/wp-content/uploads/2026/08/Copilot_20260826_115045.png" alt="How to Ensure Your Soya Paneer and Paneer Are Properly Lab Tested for Quality, Safety &amp; Authenticity" class="wp-image-13943" style="width:781px;height:auto" srcset="https://choksilab.in/wp-content/uploads/2026/08/Copilot_20260826_115045.png 1536w, https://choksilab.in/wp-content/uploads/2026/08/Copilot_20260826_115045-300x200.png 300w, https://choksilab.in/wp-content/uploads/2026/08/Copilot_20260826_115045-1024x683.png 1024w, https://choksilab.in/wp-content/uploads/2026/08/Copilot_20260826_115045-768x512.png 768w" sizes="(max-width: 1536px) 100vw, 1536px" /><figcaption class="wp-element-caption">Paneer </figcaption></figure>



<h3 class="wp-block-heading has-text-align-center has-text-color has-link-color wp-elements-8be585c2b32b3ffdc2444a14fd335443" style="color:#32700f"><strong>How to Ensure Your Soy Paneer &amp; Paneer Are Lab Tested and Safe</strong></h3>



<p class="wp-block-paragraph"></p>



<p class="has-ast-global-color-8-color has-text-color has-link-color wp-elements-9451f2f4b62b7c357a6d1d1c91c4c410 wp-block-paragraph">Paneer and soy paneer are widely consumed food products, but ensuring their <strong>quality, authenticity, nutritional accuracy and safety</strong> is essential. Laboratory testing helps assess these products for <strong>adulteration, microbiological contamination, nutritional composition and chemical contaminants</strong>.</p>



<p class="has-ast-global-color-8-color has-text-color has-link-color wp-elements-7033ce9b48d1a49aa2aa6e868a3ee710 wp-block-paragraph">With growing concerns around <strong>fake paneer, adulteration and product quality</strong>, professional laboratory testing can help manufacturers, retailers, HoReCa businesses, exporters and consumers make informed decisions about product safety and compliance.</p>



<p class="has-ast-global-color-8-color has-text-color has-link-color wp-elements-bd726a8e0e5aca610f5c5d2c3745688d wp-block-paragraph"></p>



<h6 class="wp-block-heading has-ast-global-color-0-color has-text-color has-link-color wp-elements-5a75ba15dffadb48db933ecc0d26f827"><strong>What Does Paneer Testing Cover?</strong></h6>



<p class="has-ast-global-color-8-color has-text-color has-link-color wp-elements-7c7ce2b14c34315bc65c0fa5c4344f1b wp-block-paragraph">A comprehensive paneer testing program can include:</p>



<ul class="wp-block-list">
<li class="has-ast-global-color-8-color has-text-color has-link-color wp-elements-fd29e7b23e5d54dcf82a921594332e13" style="line-height:1.7"><strong>Microbiological testing</strong></li>



<li class="has-ast-global-color-8-color has-text-color has-link-color wp-elements-fe243e35e793cae568a44f3fc3b17c82" style="line-height:1.7"><strong>Adulteration and foreign-fat detection</strong></li>



<li class="has-ast-global-color-8-color has-text-color has-link-color wp-elements-06d906e9918362aed9cfc818b0753c0a" style="line-height:1.7"><strong>Nutritional analysis</strong></li>



<li class="has-ast-global-color-8-color has-text-color has-link-color wp-elements-14e396923b1dbe3eee9d52233c445b12" style="line-height:1.7"><strong>Chemical contaminant testing</strong></li>



<li class="has-ast-global-color-8-color has-text-color has-link-color wp-elements-0812edfe7f4b2bb3044061b731d46b0d" style="line-height:1.7"><strong>Protein and ingredient identification</strong></li>



<li class="has-ast-global-color-8-color has-text-color has-link-color wp-elements-60a35aa8e02a463d47111071637f5ff2"><strong>Quality and compliance assessment</strong></li>
</ul>



<h6 class="wp-block-heading has-ast-global-color-0-color has-text-color has-link-color wp-elements-8e5485f83553607ad42aa05aa582e031"><strong>Microbiological Testing</strong></h6>



<p class="has-ast-global-color-8-color has-text-color has-link-color wp-elements-b0f2262d2067947282e3c549a8b66ce6 wp-block-paragraph">Paneer contains high moisture and protein, making it highly perishable. Microbiological testing can assess parameters such as <strong>E. coli, Salmonella, Listeria, yeast and mold, and total plate count</strong> to evaluate product safety.</p>



<h6 class="wp-block-heading has-ast-global-color-0-color has-text-color has-link-color wp-elements-5fe1a61df607852228f85239140a0b57"><strong>Adulteration &amp; Fake Paneer Testing</strong></h6>



<p class="has-ast-global-color-8-color has-text-color has-link-color wp-elements-6f4cd40f7cc77b1107b2ad279ec88856 wp-block-paragraph">Testing can help identify common adulteration indicators such as <strong>starch, synthetic milk, urea, detergent residues, foreign fat and vegetable oil markers such as β-sitosterol</strong>.</p>



<h6 class="wp-block-heading has-ast-global-color-0-color has-text-color has-link-color wp-elements-e174d50c20dfb1512f626d1c44881d9c"><strong>Nutritional Analysis</strong></h6>



<p class="has-ast-global-color-8-color has-text-color has-link-color wp-elements-21682d2f588c7adc2ac00421b7528c57 wp-block-paragraph">Laboratory analysis can verify important nutritional parameters including <strong>protein, fat, moisture and carbohydrates</strong>, helping ensure that nutritional claims are supported by laboratory results.</p>



<h6 class="wp-block-heading has-ast-global-color-0-color has-text-color has-link-color wp-elements-c1708f5921dfbe671db98e8ef8374943"><strong>Chemical Contaminant Testing</strong></h6>



<p class="has-ast-global-color-8-color has-text-color has-link-color wp-elements-e1041be8de58d9e5050db3e2e5d75d0e wp-block-paragraph">Depending on the testing requirement, laboratories can screen for <strong>heavy metals such as lead and arsenic, pesticide residues, preservative levels and antibiotic residues</strong>.</p>



<h6 class="wp-block-heading has-ast-global-color-0-color has-text-color has-link-color wp-elements-045b5f5aaca0421f9b5aa0ff70e9cb6f"><strong><strong>Why Is Soy Paneer Testing Important?</strong></strong></h6>



<p class="has-ast-global-color-8-color has-text-color has-link-color wp-elements-fbbeec9f26d0e4a8fe90b2a129ccd5b5 wp-block-paragraph">Soy paneer requires specific attention because it is a <strong>plant-based product with different quality and safety considerations</strong> compared with dairy paneer.</p>



<p class="has-ast-global-color-8-color has-text-color has-link-color wp-elements-b76eba60326ddea52511e90c5ccc2d31 wp-block-paragraph">A detailed soy paneer testing program may include:</p>



<ul class="wp-block-list">
<li class="has-ast-global-color-8-color has-text-color has-link-color wp-elements-f250f24f85e0a54b623303cc25d55574" style="line-height:1.7"><strong>Soy protein quality analysis</strong></li>



<li class="has-ast-global-color-8-color has-text-color has-link-color wp-elements-ecf7379a5f18d8299ea050c4cae822a1" style="line-height:1.7"><strong>Allergen declaration verification</strong></li>



<li class="has-ast-global-color-8-color has-text-color has-link-color wp-elements-d4e52ddca71129f7738deb834f0cd22c" style="line-height:1.7"><strong>Heavy metal testing</strong></li>



<li class="has-ast-global-color-8-color has-text-color has-link-color wp-elements-cd5a4ab61c3601b9d04effef5269bbf0"><strong>Microbiological safety analysis</strong></li>



<li class="has-ast-global-color-8-color has-text-color has-link-color wp-elements-e4b1f4c12e82460731110967ae209eeb"><strong>Shelf-life testing</strong></li>
</ul>



<p class="has-ast-global-color-8-color has-text-color has-link-color wp-elements-26a00e2282801fd5a8daaf081bc038e3 wp-block-paragraph">Since soy is a common allergen, appropriate testing and accurate declaration are important considerations for product labeling and consumer safety.</p>



<h6 class="wp-block-heading has-ast-global-color-0-color has-text-color has-link-color wp-elements-f656a50d85ab3f407c5f3a5a5ff143d6"><strong>Why Should Food Businesses Test Paneer?</strong></h6>



<p class="has-ast-global-color-8-color has-text-color has-link-color wp-elements-8d00228980b0deb6c802df79d60d7ec4 wp-block-paragraph">For manufacturers, retailers, HoReCa suppliers and exporters, regular laboratory testing can help reduce risks related to:</p>



<p class="has-ast-global-color-8-color has-text-color has-link-color wp-elements-0ee55cf80fe96c5b47aadacd2cc9eb6e wp-block-paragraph"><strong>Regulatory penalties • Product recalls • Brand damage • Legal liabilities • Customer complaints</strong> </p>



<p class="has-ast-global-color-8-color has-text-color has-link-color wp-elements-6b7dac1b970b24eb443c5010217d8961 wp-block-paragraph">Testing also supports <strong>regulatory compliance, brand trust, export requirements and reduction of product-recall risks</strong>.</p>



<h6 class="wp-block-heading has-ast-global-color-0-color has-text-color has-link-color wp-elements-6a05532b03deccdc3950f487cc892190"></h6>



<h5 class="wp-block-heading has-text-align-center has-ast-global-color-0-color has-text-color has-link-color wp-elements-6eeac95206eb64b339f2319b277e5873"><strong>Read the Complete Guide</strong></h5>



<p class="wp-block-paragraph"></p>



<p class="has-ast-global-color-8-color has-text-color has-link-color wp-elements-aa8c77057610b530fda98da2e785004c wp-block-paragraph">For detailed information on paneer and soy paneer testing, adulteration detection, food-safety parameters and laboratory testing considerations, download or view our complete guide below.</p>



<p class="has-ast-global-color-8-color has-text-color has-link-color wp-elements-bd726a8e0e5aca610f5c5d2c3745688d wp-block-paragraph"></p>



<p class="wp-block-paragraph"></p>



<div data-wp-interactive="core/file" class="wp-block-file"><object data-wp-bind--hidden="!state.hasPdfPreview" hidden class="wp-block-file__embed" data="https://choksilab.in/wp-content/uploads/2026/08/paneer-analog.pdf-5.pdf" type="application/pdf" style="width:100%;height:600px" aria-label="Embed of paneer analog.pdf (5)."></object><a id="wp-block-file--media-5de83f82-33ee-4160-8da1-b5775f9a1be8" href="https://choksilab.in/wp-content/uploads/2026/08/paneer-analog.pdf-5.pdf">paneer analog.pdf (5)</a><a href="https://choksilab.in/wp-content/uploads/2026/08/paneer-analog.pdf-5.pdf" class="wp-block-file__button wp-element-button" download aria-describedby="wp-block-file--media-5de83f82-33ee-4160-8da1-b5775f9a1be8">Download</a></div>



<p class="has-ast-global-color-8-color has-text-color has-link-color wp-elements-a64ac9e0808dc46205e16a7691c344f4 wp-block-paragraph"><strong>Choksi Laboratories </strong>provides comprehensive analytical testing solutions to support<strong> food quality, safety, authenticity and regulatory compliance</strong>, helping businesses make informed decisions and maintain confidence in their products.</p>



<p class="has-ast-global-color-8-color has-text-color has-link-color wp-elements-bd726a8e0e5aca610f5c5d2c3745688d wp-block-paragraph"></p>



<h5 class="wp-block-heading has-text-align-center has-ast-global-color-0-color has-text-color has-link-color wp-elements-0565a6f2683c82f44dd48ab046ea8539"><strong>Test. Verify. Trust.</strong></h5>



<p class="wp-block-paragraph"></p>



<p class="has-text-align-center has-ast-global-color-8-color has-text-color has-link-color wp-elements-7973fab00dea25d463f6f99f3b93174c wp-block-paragraph"><strong>Reliable laboratory testing helps support food quality, product authenticity, consumer safety and regulatory compliance.</strong></p>



<p class="wp-block-paragraph"></p><p>The post <a href="https://choksilab.in/how-to-ensure-your-soya-paneer-and-paneer-are-lab-tested-and-safe/">How to Ensure Your Soya Paneer and Paneer Are Properly Lab Tested for Quality, Safety & Authenticity</a> first appeared on <a href="https://choksilab.in">Choksi Laboratories</a>.</p>]]></content:encoded>
					
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		<title>Choksi Laboratories Receives Enhanced CDSCO Approval for Medical Devices Quality Assessment</title>
		<link>https://choksilab.in/choksi-laboratories-receives-enhanced-cdsco-approval-for-medical-devices-quality-assessment/</link>
					<comments>https://choksilab.in/choksi-laboratories-receives-enhanced-cdsco-approval-for-medical-devices-quality-assessment/#respond</comments>
		
		<dc:creator><![CDATA[admin_choksi]]></dc:creator>
		<pubDate>Tue, 11 Mar 2025 04:57:01 +0000</pubDate>
				<category><![CDATA[Latest news]]></category>
		<guid isPermaLink="false">https://choksilab.in/?p=10432</guid>

					<description><![CDATA[<p>Choksi Laboratories Receives Enhanced CDSCO Approval for Medical Devices Quality Assessment We are thrilled to announce that Choksi Laboratories Limited (CLL) has received enhanced scope approval from the Central Drugs Standard Control Organization (CDSCO) for the testing and evaluation of medical devices. This expansion strengthens our commitment to ensuring high-quality and regulatory-compliant medical devices for the healthcare industry. Expanded Scope of Testing The approval now covers 59 medical devices across various classes, allowing CLL to conduct comprehensive chemical, microbiological, and elemental analysis. Some of the critical quality parameters included in our expanded scope are: Chemical Characterization – Identification of the chemical composition of medical devices. Extractables and Leachables Assessment – Evaluating potential chemical compounds that may migrate from the device to the patient. Sterilization Residues Testing – Detection of Ethylene Glycol (EG), Diethylene Glycol (DEG), Ethylene Oxide (EO), and Ethylene Chlorohydrin (ECH) to ensure product safety. Elemental Analysis – Determining the presence of extractable and total elements that could impact device performance and safety. CLL already had an approved scope for microbiological testing of medical devices. With this enhanced scope, we are now positioned to provide a comprehensive suite of quality assessment services for a broader range of medical devices.  Medical Devices Covered in the Expanded Scope Our state-of-the-art laboratory can now test and evaluate a diverse range of medical devices, including but not limited to: IV Bags and Sets Catheters Lenses &#38; Contact Lenses Dental Implants and Orthopedic Implants Cardiovascular Devices and Stents Surgical &#38; Non-Surgical Gloves Intrauterine Devices (IUDs) Nebulizers, Aspirators, and Inhalers Face Masks, Nasal Masks, and Oral Masks Commitment to Quality and Compliance At Choksi Laboratories, we uphold the highest standards of testing and regulatory compliance. Our advanced analytical capabilities, combined with our expertise in pharmaceutical and medical device testing, ensure that we deliver reliable, accurate, and regulatory-compliant results. With this CDSCO-approved enhanced scope, we reaffirm our commitment to supporting medical device manufacturers, importers, and healthcare providers in delivering safe and effective medical solutions to the market.🔬 For inquiries about our medical device testing services, contact us today!  </p>
<p>The post <a href="https://choksilab.in/choksi-laboratories-receives-enhanced-cdsco-approval-for-medical-devices-quality-assessment/">Choksi Laboratories Receives Enhanced CDSCO Approval for Medical Devices Quality Assessment</a> first appeared on <a href="https://choksilab.in">Choksi Laboratories</a>.</p>]]></description>
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					<h2 class="elementor-heading-title elementor-size-default">Choksi Laboratories Receives Enhanced CDSCO Approval for Medical Devices Quality Assessment</h2>				</div>
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									<p>We are thrilled to announce that <b>Choksi Laboratories Limited (CLL)</b> has received <b>enhanced scope approval</b> from the <b>Central Drugs Standard Control Organization (CDSCO)</b> for the <b>testing and evaluation of medical devices</b>. This expansion strengthens our commitment to ensuring <b>high-quality and regulatory-compliant medical devices</b> for the healthcare industry.</p><p><span style="color: #0d7dde;"><strong>Expanded Scope of Testing</strong></span></p><div data-olk-copy-source="MessageBody">The approval now covers <b>59 medical devices</b> across various classes, allowing CLL to conduct comprehensive <b>chemical, microbiological, and elemental analysis</b>. Some of the critical quality parameters included in our expanded scope are:</div><ul data-end="1359" data-start="802"><li><b>Chemical Characterization</b> – Identification of the chemical composition of medical devices.</li><li><b>Extractables and Leachables Assessment</b> – Evaluating potential chemical compounds that may migrate from the device to the patient.</li><li><b>Sterilization Residues Testing</b> – Detection of <b>Ethylene Glycol (EG), Diethylene Glycol (DEG), Ethylene Oxide (EO), and Ethylene Chlorohydrin (ECH)</b> to ensure product safety.</li><li><b>Elemental Analysis</b> – Determining the presence of extractable and total elements that could impact device performance and safety.</li></ul><div>CLL already had an <b>approved scope for microbiological testing</b> of medical devices. With this <b>enhanced scope</b>, we are now positioned to provide a <b>comprehensive suite of quality assessment services</b> for a broader range of medical devices.</div><div> </div><p><span style="color: #0d7dde;"><strong>Medical Devices Covered in the Expanded Scope</strong></span></p><div><span data-olk-copy-source="MessageBody">Our </span><b>state-of-the-art laboratory</b> can now test and evaluate <b>a diverse range of medical devices</b>, including but not limited to:</div><ul><li><b>IV Bags and Sets</b><br /><b></b></li><li><b>Catheters</b><br /><b></b></li><li><b>Lenses &amp; Contact </b><b>Lenses</b><br /><b></b></li><li><b>Dental Implants and </b><b>Orthopedic Implants</b><br /><b></b></li><li><b>Cardiovascular </b><b>Devices and Stents</b><br /><b></b></li><li><b>Surgical &amp; Non-Surgical Gloves</b></li><li><b>Intrauterine Devices (IUDs)</b><br /><b></b></li><li><b>Nebulizers, Aspirators, and Inhalers</b><br /><b></b></li><li><b>Face Masks, Nasal Masks, and Oral Masks</b></li></ul>								</div>
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					<h2 class="elementor-heading-title elementor-size-default">Commitment to Quality and Compliance</h2>				</div>
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									<p>At <b>Choksi Laboratories</b>, we uphold the <b>highest standards of testing and regulatory compliance</b>. Our advanced analytical capabilities, combined with our expertise in pharmaceutical and medical device testing, ensure that we deliver <b>reliable, accurate, and regulatory-compliant results</b>.</p><div data-olk-copy-source="MessageBody">With this <b>CDSCO-approved enhanced scope</b>, we reaffirm our commitment to supporting <b>medical device manufacturers, importers, and healthcare providers</b> in delivering <b>safe and effective medical solutions</b> to the market.</div><div>🔬 <b>For inquiries about our medical device testing services, contact us today!</b></div><p> </p>								</div>
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		<title>Nitrate, Nitrite, and NDMA Contaminants in Lactose: Analytical Insights and Regulatory Perspectives</title>
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		<pubDate>Tue, 13 Aug 2024 10:39:55 +0000</pubDate>
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					<description><![CDATA[<p>Nitrate, Nitrite and NDMA in Lactose Risk Assessment and Analytical Perspective What is Lactose? Lactose is a sugar (disaccharide) naturally present in milk. About 2-8% of milk content by weight is Lactose. Lactose contains one molecule of glucose and one molecule of galactose. Lactase, an enzyme in human gut, breaks down the Lactose in its constituents. Lactose Applications in Food and Pharmaceuticals Lactose is used mainly in infant milk powders, food additives and in pharmaceutical formulations as an excipient. Its physico-chemical properties such as compressibility and palatability make it an ideal excipient for pharmaceutical preparations. Several OTC drugs such as painkillers, anti-inflammatory drugs, antacids, birth-control pills, dry powder inhalation products etc. use Lactose as a diluent, excipient or carrier. How is Lactose manufactured? Commercially available lactose is manufactured by evaporation, crystallization, and refining from whey permeate separated after production of cheese &#38; other milk products. Nitrate, Nitrites and Nitrosamines in Lactose Relationship of Nitrate, Nitrites and Nitrosamines Nitrate and Nitrite are naturally present in milk from various sources such as ingestion of nitrates and nitrites by dairy cows during grazing and drinking, nitric acid used during the sanitization of dairy equipment, etc. A 2008 study4 carried out on several market drugs, provided following Lactose contents: Group name Generic name Lactose per tablet (mg) Maximum no. tablets per day Theoretical total lactose ingested per day (mg) Antimuscarinics Dicycloverine hydrochloride 74 6 444 Propantheline bromide 38 8 304 Other antispasmodics Mebeverine hydrochoride 95 3 285 99 3 297 Anti-motility drugs Codeine phosphate 46 8 368 Loperamide hydrochloride 125 8 1000 108 8 864 Aminosalicylates Mesalazine 75 6 450 Corticosteroids Budesonide 600 3 1800 Prednisolone 31 12 372 Immunosuppressants Azathioprine 71 3.5 248.5 Mercaptopurine 61 2 122 Methotrexate 28.9 6 173.4 Nitrate and/or Nitrite react through various biological or chemical processes convert to NDMA3,4. Some of the processes in production of milk powder / lactose such as equipment disinfection, acidification, and heating in directly heated spray dryers, may cause production of NDMA in final product. One of the possible routes of NDMA formation from Nitrite ion NDMA is a known carcinogen and an analyte of concern. The ADI (Acceptable Daily Intake) established by US-FDA for NDMA is 96ng/day. Roughly, this translates to following limits in lactose assuming a 100mg/tablet lactose contribution: Excipient Theoretical Intake (Dose) per day QC Specification Limit &#8211; NDMA Lactose(100mg/tablet) One tablet daily dose 0.96ppm Two tablets daily dose 0.16ppm Four tablets daily dose 0.08ppm Given this, lactose has a major potential to contribute Nitrate, Nitrite or NDMA itself to the drug product. Nitrite, Nitrate Acceptable Daily Intake A study1 published by US-FDA researchers in Journal of Agricultural and Food Chemistry, in January 2020, reviewed Nitrate, Nitrites in animal as well as plant based milk and milk products. The study found that out of 71 commercial milk powder samples, 67 had Nitrate content &#62; 1.5mg/kg (1.9mg/kg being the lowest and 395mg/kg being the highest). In addition, a smaller subset of these samples were also tested for NDMA content and found NDMA content in all tested samples Acceptable Daily Intakes for Nitrate and Nitrite as per WHO Nitrate ADI Nitrite ADI ADI (mg/Kg of body-weight) 3.7 0.07 Limits for an Adult, mg/Day (60kg body weight) 222 4.2 Analytical Method by Choksi Laboratories Ltd. Lactose is a challenging matrix as the sugar can lead to rapid column degradation. Therefore, it is extremely important to ensure that the column loading is managed to ensure that nitrate and nitrite are separate well while reducing matrix interference to minimum. We used a Dionex 5000plus Ion Chromatogram equipped with ASRS 300. IonPac®AS14A Analytical 4 × 250 mm column was used with analytical guard column of same packing. Nitrate, Nitrites and Nitrosamines in Lactose Standards and samples were matrix matched by using standard addition method, to further reduce interference. System Suitability: As can be seen in the chromatogram, both Nitrate and Nitrite were well resolved. There was no matrix interference. And a linear regression determined the coefficient of determination to be 0.9996 (well over the acceptance limit of 0.995). Results: Lactose samples typically showed nitrate concentrations at about 1.9ppm to 10ppm. Nitrite was not detected in any sample tested in the study. Further NDMA studies were carried out in GC-HS-MS/MS equipped with HES source, and utilized back-flushing technique to remove other contaminants from column. LOD/LOQ: Typical LOD, LOQ values established are given below: Nitrate, ppm Nitrite, ppm NDMA, ppm LOD* 0.005 0.005 0.001 LOQ* 0.01 0.01 0.003 (*): On instrument With this study at CLL-Indore, a rapid methodology was established to analyze Nitrate and Nitrite in Lactose samples, followed by NDMA estimation by GC-HS- MS/MS, meeting current regulatory requirements quite easily. Reference Documents: J. Agric. Food Chem. 2020, 68, 6, 1725– 1730, Publication Date: January 22, 2020 : Investigation into the Concentrations and Sources of Nitrates and Nitrites in Milk and Plant-based Powders, Susan Genualdi, Mayara P. V. Matos, John B. Mangrum, Lowri DeJager WHO/HSE/AMR/08.03/8: N- Nitrosodimethylamine in Drinking-water, Background document for development of WHO Guidelines for Drinking-water Quality, 2008 EPA Technical Fact Sheet – N-Nitroso- dimethylamine (NDMA), January 2014 Quantifying the ‘hidden’ lactose in drugs used for the treatment of gastrointestinal conditions, P. EADALA,J. P. WAUD,S. B. MATTHEWS,J. T. GREEN,A. K. CAMPBEL.</p>
<p>The post <a href="https://choksilab.in/nitrate-nitrite-and-ndma-in-lactose/">Nitrate, Nitrite, and NDMA Contaminants in Lactose: Analytical Insights and Regulatory Perspectives</a> first appeared on <a href="https://choksilab.in">Choksi Laboratories</a>.</p>]]></description>
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					<h2 class="elementor-heading-title elementor-size-default">Nitrate, Nitrite and NDMA in Lactose</h2>				</div>
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					<h2 class="elementor-heading-title elementor-size-default">Risk Assessment and Analytical Perspective</h2>				</div>
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									<p><span style="color: #457720;"><strong>What is Lactose?</strong></span><br />Lactose is a sugar (disaccharide) naturally present in milk. About 2-8% of milk content by weight is Lactose. Lactose contains one molecule of glucose and one molecule of galactose. Lactase, an enzyme in human gut, breaks down the Lactose in its constituents.</p><p><img decoding="async" class="size-full wp-image-8567" src="https://choksilab.in/wp-content/uploads/2024/05/1.png" alt="Action" width="200" height="69" /></p><p><span style="color: #457720;"><strong>Lactose Applications in Food and Pharmaceuticals</strong></span><br />Lactose is used mainly in infant milk powders, food additives and in pharmaceutical formulations as an excipient. Its physico-chemical properties such as compressibility and palatability make it an ideal excipient<br />for pharmaceutical preparations. Several OTC drugs such as painkillers, anti-inflammatory drugs, antacids, birth-control pills, dry powder inhalation products etc. use Lactose as a diluent, excipient or carrier.</p><p><span style="color: #457720;"><strong>How is Lactose manufactured?</strong></span><br />Commercially available lactose is manufactured by evaporation, crystallization, and refining from whey permeate separated after production of cheese &amp; other milk products.</p>								</div>
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					<h2 class="elementor-heading-title elementor-size-default">Nitrate, Nitrites and Nitrosamines in Lactose</h2>				</div>
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									<p><span style="color: #457720;"><strong>Relationship of Nitrate, Nitrites and Nitrosamines</strong></span><br />Nitrate and Nitrite are naturally present in milk from various sources such as ingestion of nitrates and nitrites by dairy cows during grazing and drinking, nitric acid used during the sanitization of dairy equipment, etc.</p><p>    A 2008 study4 carried out on several market drugs, provided following Lactose contents:</p><table><tbody><tr><td width="119"><p><strong>Group name</strong></p></td><td width="152"><p><strong>Generic name</strong></p></td><td width="87"><p><strong>Lactose per</strong></p><p><strong>tablet (mg)</strong></p></td><td width="133"><p><strong>Maximum no. tablets</strong></p><p><strong>per day</strong></p></td><td width="140"><p><strong>Theoretical total lactose</strong></p><p><strong>ingested per day (mg)</strong></p></td></tr><tr><td rowspan="2" width="119"><p>Antimuscarinics</p></td><td width="152"><p>Dicycloverine hydrochloride</p></td><td width="87"><p>74</p></td><td width="133"><p>6</p></td><td width="140"><p>444</p></td></tr><tr><td width="152"><p>Propantheline bromide</p></td><td width="87"><p>38</p></td><td width="133"><p>8</p></td><td width="140"><p>304</p></td></tr><tr><td rowspan="2" width="119"><p>Other</p><p>antispasmodics</p></td><td rowspan="2" width="152"><p>Mebeverine hydrochoride</p></td><td width="87"><p>95</p></td><td width="133"><p>3</p></td><td width="140"><p>285</p></td></tr><tr><td width="87"><p>99</p></td><td width="133"><p>3</p></td><td width="140"><p>297</p></td></tr><tr><td rowspan="3" width="119"><p>Anti-motility drugs</p></td><td width="152"><p>Codeine phosphate</p></td><td width="87"><p>46</p></td><td width="133"><p>8</p></td><td width="140"><p>368</p></td></tr><tr><td rowspan="2" width="152"><p>Loperamide hydrochloride</p></td><td width="87"><p>125</p></td><td width="133"><p>8</p></td><td width="140"><p>1000</p></td></tr><tr><td width="87"><p>108</p></td><td width="133"><p>8</p></td><td width="140"><p>864</p></td></tr><tr><td width="119"><p>Aminosalicylates</p></td><td width="152"><p>Mesalazine</p></td><td width="87"><p>75</p></td><td width="133"><p>6</p></td><td width="140"><p>450</p></td></tr><tr><td rowspan="2" width="119"><p>Corticosteroids</p></td><td width="152"><p>Budesonide</p></td><td width="87"><p>600</p></td><td width="133"><p>3</p></td><td width="140"><p>1800</p></td></tr><tr><td width="152"><p>Prednisolone</p></td><td width="87"><p>31</p></td><td width="133"><p>12</p></td><td width="140"><p>372</p></td></tr><tr><td rowspan="3" width="119"><p>Immunosuppressants</p></td><td width="152"><p>Azathioprine</p></td><td width="87"><p>71</p></td><td width="133"><p>3.5</p></td><td width="140"><p>248.5</p></td></tr><tr><td width="152"><p>Mercaptopurine</p></td><td width="87"><p>61</p></td><td width="133"><p>2</p></td><td width="140"><p>122</p></td></tr><tr><td width="152"><p>Methotrexate</p></td><td width="87"><p>28.9</p></td><td width="133"><p>6</p></td><td width="140"><p>173.4</p></td></tr></tbody></table><p>Nitrate and/or Nitrite react through various biological or chemical processes convert to NDMA<sup>3,4</sup>. Some of the processes in production of milk powder / lactose such as equipment disinfection, acidification, and heating in directly heated spray dryers, may cause production of NDMA in final product.</p><p><img decoding="async" class="size-full wp-image-8569" src="https://choksilab.in/wp-content/uploads/2024/05/NDMA.jpg" alt="NDMA" width="247" height="120" /></p><p><span style="color: #457720;"><strong><em>One of the possible routes of NDMA formation from Nitrite ion</em></strong></span></p><p>NDMA is a known carcinogen and an analyte of concern. The ADI (Acceptable Daily Intake) established by US-FDA for NDMA is 96ng/day. Roughly, this translates to following limits in lactose assuming a 100mg/tablet lactose contribution:</p><table width="671"><tbody><tr><td width="182"><strong>Excipient</strong></td><td width="254"><strong>Theoretical Intake (Dose) per day</strong></td><td width="235"><strong>QC Specification Limit &#8211; NDMA</strong></td></tr><tr><td rowspan="3" width="182">Lactose(100mg/tablet)</td><td width="254">One tablet daily dose</td><td width="235">0.96ppm</td></tr><tr><td width="254">Two tablets daily dose</td><td width="235">0.16ppm</td></tr><tr><td width="254">Four tablets daily dose</td><td width="235">0.08ppm</td></tr></tbody></table><p><span style="color: #457720;"><strong>Given this, lactose has a major potential to contribute Nitrate, Nitrite or NDMA itself to the drug product.</strong></span></p><p><span style="color: #457720;"><strong>Nitrite, Nitrate Acceptable Daily Intake</strong></span></p><p>A study<sup>1</sup> published by US-FDA researchers in Journal of Agricultural and Food Chemistry, in January 2020, reviewed Nitrate, Nitrites in animal as well as plant based milk and milk products.</p><p>The study found that out of 71 commercial milk powder samples, 67 had Nitrate content &gt; 1.5mg/kg (1.9mg/kg being the lowest and 395mg/kg being the highest). In addition, a smaller subset of these samples were also tested for NDMA content and found NDMA content in <strong><u>all</u> </strong>tested samples</p><table width="385"><tbody><tr><td style="text-align: center;" colspan="3" width="385"><span style="color: #457720;"><strong>Acceptable Daily Intakes for Nitrate and Nitrite as per WHO</strong></span></td></tr><tr><td> </td><td><strong>Nitrate ADI</strong></td><td><strong>Nitrite ADI</strong></td></tr><tr><td width="139"><strong>ADI</strong><br /><strong>(mg/Kg of body-weight)</strong></td><td>3.7</td><td>0.07</td></tr><tr><td width="139"><strong>Limits for an Adult, mg/Day</strong><br /><strong>(60kg body weight)</strong></td><td>222</td><td>4.2</td></tr></tbody></table><p><span style="color: #457720;"><strong>Analytical Method by Choksi Laboratories Ltd.</strong></span></p><p>Lactose is a challenging matrix as the sugar can lead to rapid column degradation. Therefore, it is extremely important to ensure that the column loading is managed to ensure that nitrate and nitrite are separate well while reducing matrix interference to minimum.</p><p>We used a Dionex 5000plus Ion Chromatogram equipped with ASRS 300. IonPac®AS14A Analytical 4 × 250 mm column was used with analytical guard column of same packing.</p>								</div>
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															<img loading="lazy" decoding="async" width="322" height="192" src="https://choksilab.in/wp-content/uploads/2024/05/6.jpg" class="attachment-large size-large wp-image-8576" alt="graph" srcset="https://choksilab.in/wp-content/uploads/2024/05/6.jpg 322w, https://choksilab.in/wp-content/uploads/2024/05/6-300x179.jpg 300w" sizes="(max-width: 322px) 100vw, 322px" title="Nitrate, Nitrite, and NDMA Contaminants in Lactose: Analytical Insights and Regulatory Perspectives" />															</div>
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					<h2 class="elementor-heading-title elementor-size-default">Nitrate, Nitrites and Nitrosamines in Lactose</h2>				</div>
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									<p>Standards and samples were matrix matched by using standard addition method, to further reduce interference.</p><p><span style="color: #0da6e2;"><strong>System Suitability: </strong></span>As can be seen in the chromatogram, both Nitrate and Nitrite were well resolved. There was no matrix interference. And a linear regression determined the coefficient of determination to be 0.9996 (well over the acceptance limit of 0.995).</p><p><strong><span style="color: #0da6e2;">Results:</span> </strong>Lactose samples typically showed nitrate concentrations at about 1.9ppm to 10ppm. Nitrite was not detected in any sample tested in the study. Further NDMA studies were carried out in GC-HS-MS/MS equipped with HES source, and utilized back-flushing technique to remove other contaminants from column.</p><p><span style="color: #0da6e2;"><strong>LOD/LOQ: </strong></span>Typical LOD, LOQ values established are given below:</p><table width="1073"><tbody><tr><td width="304"> </td><td width="261"><span style="color: #0da6e2;">Nitrate, ppm</span></td><td width="278"><span style="color: #0da6e2;">Nitrite, ppm</span></td><td width="230"><span style="color: #0da6e2;">NDMA, ppm</span></td></tr><tr><td width="304"><span style="color: #0da6e2;">LOD*</span></td><td width="261">0.005</td><td width="278">0.005</td><td width="230">0.001</td></tr><tr><td width="304"><span style="color: #0da6e2;">LOQ*</span></td><td width="261">0.01</td><td width="278">0.01</td><td width="230">0.003</td></tr><tr><td style="text-align: right;" colspan="4">(*): On instrument</td></tr></tbody></table><p><span style="color: #0da6e2;">With this study at CLL-Indore, a rapid methodology was established to analyze Nitrate and Nitrite in Lactose samples, followed by NDMA estimation by GC-HS- MS/MS, meeting current regulatory requirements quite easily.</span></p>								</div>
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					<h2 class="elementor-heading-title elementor-size-default">Reference Documents:</h2>				</div>
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									<ol><li>J. Agric. Food Chem. 2020, 68, 6, 1725– 1730, Publication Date: January 22, 2020 : Investigation into the Concentrations and Sources of Nitrates and Nitrites in Milk and Plant-based Powders, Susan Genualdi, Mayara P. V. Matos, John B. Mangrum, Lowri DeJager</li><li>WHO/HSE/AMR/08.03/8: N- Nitrosodimethylamine in Drinking-water, Background document for development of WHO Guidelines for Drinking-water Quality, 2008</li><li>EPA Technical Fact Sheet – N-Nitroso- dimethylamine (NDMA), January 2014</li><li>Quantifying the ‘hidden’ lactose in drugs used for the treatment of gastrointestinal conditions, P. EADALA,J. P. WAUD,S. B. MATTHEWS,J. T. GREEN,A. K. CAMPBEL.</li></ol>								</div>
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				</div><p>The post <a href="https://choksilab.in/nitrate-nitrite-and-ndma-in-lactose/">Nitrate, Nitrite, and NDMA Contaminants in Lactose: Analytical Insights and Regulatory Perspectives</a> first appeared on <a href="https://choksilab.in">Choksi Laboratories</a>.</p>]]></content:encoded>
					
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					<description><![CDATA[<p>The U.S. Food and Drug Administration (FDA) has expanded its public health alert to include more ground cinnamon products due to the presence of elevated levels of lead. This action follows rigorous product testing conducted by state programs and confirmed by the FDA. Consumers are strongly advised to dispose of and refrain from purchasing these products. Key Points of the Alert: Elevated Lead Levels Detected: Recent testing has revealed that certain ground cinnamon products contain elevated levels of lead. These products pose a significant health risk, particularly with prolonged exposure, and should be discarded immediately. Voluntary Recalls: The FDA has recommended that companies voluntarily recall these products. The list of affected products continues to grow as more brands are identified. The FDA will update this alert with information from companies that agree to recall their products. Ongoing Investigation: The FDA, in collaboration with state partners, is continuing to analyze ground cinnamon samples. This public health alert will be updated as more data becomes available. As of now, no illnesses or adverse events related to these products have been reported. Background: This is the third public health alert issued by the FDA this year concerning ground cinnamon, reflecting the agency’s commitment to ensuring the safety of food products, especially those frequently consumed by children. The alert recommends recalls of nine brands of ground cinnamon, with lead levels ranging from 2.03 to 7.01 parts per million (ppm). These levels, while lower than those found in the WanaBana cinnamon apple puree and applesauce products recalled in 2023, still present a significant health risk. The FDA’s targeted assessment and subsequent alerts have been supported by data collected through the Laboratory Flexible Funding Model (LFFM), a cooperative agreement with state partners. States including California, Maryland, Missouri, Connecticut, and Virginia, along with the New York State Department of Agriculture and Markets, have contributed to the sampling efforts. Recommendations for Consumers: Check and Dispose: Consumers should immediately check their homes for ground cinnamon products and dispose of any items listed in the alert. These products have a long shelf life, so it’s important to verify any ground cinnamon you may have stored. Do Not Use or Purchase: Avoid using or purchasing ground cinnamon products identified in the alert. The FDA advises against consuming, selling, or serving these products due to the health risks associated with lead exposure. Seek Medical Advice: If there is any suspicion of lead exposure, particularly for vulnerable groups such as children and pregnant women, contact your healthcare provider for guidance. Although many people may not exhibit immediate symptoms of lead exposure, prolonged ingestion can lead to serious health complications. Report Adverse Events: If you or someone you know experiences adverse effects or illness after using these products, report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program. You can submit reports online, by fax, or by mail. For more detailed information about this alert and the list of affected products, please visit the FDA’s official MedWatch page.</p>
<p>The post <a href="https://choksilab.in/fda-expands-cinnamon-recall-for-lead-contamination/">FDA Expands Ground Cinnamon Recall Due to Lead Contamination: Comprehensive Public Health Alert and Consumer Safety Recommendations</a> first appeared on <a href="https://choksilab.in">Choksi Laboratories</a>.</p>]]></description>
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									<p>The U.S. Food and Drug Administration (FDA) has expanded its public health alert to include more ground cinnamon products due to the presence of elevated levels of lead. This action follows rigorous product testing conducted by state programs and confirmed by the FDA. Consumers are strongly advised to dispose of and refrain from purchasing these products.&nbsp;</p>								</div>
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					<h2 class="elementor-heading-title elementor-size-default">Key Points of the Alert:</h2>				</div>
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									<ul><li><p><span style="color: #de8a35;"><strong>Elevated Lead Levels Detected:</strong> </span>Recent testing has revealed that certain ground cinnamon products contain elevated levels of lead. These products pose a significant health risk, particularly with prolonged exposure, and should be discarded immediately.</p></li><li><p><span style="color: #de8a35;"><strong>Voluntary Recalls:</strong></span> The FDA has recommended that companies voluntarily recall these products. The list of affected products continues to grow as more brands are identified. The FDA will update this alert with information from companies that agree to recall their products.</p></li><li><p><span style="color: #de8a35;"><strong>Ongoing Investigation:</strong> </span>The FDA, in collaboration with state partners, is continuing to analyze ground cinnamon samples. This public health alert will be updated as more data becomes available. As of now, no illnesses or adverse events related to these products have been reported.</p></li></ul>								</div>
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					<h2 class="elementor-heading-title elementor-size-default">Background:</h2>				</div>
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									<p>This is the third public health alert issued by the FDA this year concerning ground cinnamon, reflecting the agency’s commitment to ensuring the safety of food products, especially those frequently consumed by children. The alert recommends recalls of nine brands of ground cinnamon, with lead levels ranging from 2.03 to 7.01 parts per million (ppm). These levels, while lower than those found in the WanaBana cinnamon apple puree and applesauce products recalled in 2023, still present a significant health risk.</p><p>The FDA’s targeted assessment and subsequent alerts have been supported by data collected through the Laboratory Flexible Funding Model (LFFM), a cooperative agreement with state partners. States including California, Maryland, Missouri, Connecticut, and Virginia, along with the New York State Department of Agriculture and Markets, have contributed to the sampling efforts.</p>								</div>
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					<h2 class="elementor-heading-title elementor-size-default">Recommendations for Consumers:</h2>				</div>
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									<ul><li><p><span style="color: #de8a35;"><strong>Check and Dispose:</strong></span> Consumers should immediately check their homes for ground cinnamon products and dispose of any items listed in the alert. These products have a long shelf life, so it’s important to verify any ground cinnamon you may have stored.</p></li><li><p><span style="color: #de8a35;"><strong>Do Not Use or Purchase:</strong></span> Avoid using or purchasing ground cinnamon products identified in the alert. The FDA advises against consuming, selling, or serving these products due to the health risks associated with lead exposure.</p></li><li><p><span style="color: #de8a35;"><strong>Seek Medical Advice:</strong></span> If there is any suspicion of lead exposure, particularly for vulnerable groups such as children and pregnant women, contact your healthcare provider for guidance. Although many people may not exhibit immediate symptoms of lead exposure, prolonged ingestion can lead to serious health complications.</p></li><li><p><span style="color: #de8a35;"><strong>Report Adverse Events:</strong></span> If you or someone you know experiences adverse effects or illness after using these products, report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program. You can submit reports online, by fax, or by mail.</p></li></ul>								</div>
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									<p>For more detailed information about this alert and the list of affected products, please visit the FDA’s official <a target="_new" rel="noreferrer">MedWatch page</a>.</p>								</div>
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				</div><p>The post <a href="https://choksilab.in/fda-expands-cinnamon-recall-for-lead-contamination/">FDA Expands Ground Cinnamon Recall Due to Lead Contamination: Comprehensive Public Health Alert and Consumer Safety Recommendations</a> first appeared on <a href="https://choksilab.in">Choksi Laboratories</a>.</p>]]></content:encoded>
					
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