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<blockquote data-quote="Davy Crockett" data-source="post: 249994" data-attributes="member: 367"><p>I was digging for whatever information I could find on this kratom stuff and at the FDA website I noticed a recall on one of my meds due to traces of carcinogen (cancer causing agent) . There was no lot # on my container to confirm if mine was part of the recall or not so I emailed FDA a question . </p><p></p><p>Me to FDA ~ "<span style="font-family: 'Arial'"> I noticed a recent recall on Losartan due to possible </span><span style="font-family: 'Roboto'"><span style="color: #545454">carcinogen contamination and I see the affected lot # posted on your website but when I looked for the lot # on the packaging provided by my pharmacy I was surprised that there isn't one. Are we at the mercy of relying on our pharmacy to contact us about recalls or what is the safety procedure when recalls occur ?" </span></span></p><p><span style="font-family: 'Roboto'"><span style="color: #545454"></span></span></p><p><span style="font-family: 'Roboto'"><span style="color: #545454"></span></span></p><p><span style="font-family: 'Roboto'"><span style="color: #545454">FDA response~ " </span></span></p><p></p><p><span style="font-family: 'Arial'"><span style="color: black"><span style="font-family: 'Arial'">We greatly appreciate your time and effort in contacting the FDA to share your concern regarding the losartan drug recall. We understand your frustration with the limited information provided by your pharmacy. We recommend that you contact your pharmacy to obtain the lot number but we understand that if your medication was dispensed to you in the pharmacy’s container, then it may be difficult to track the lot number you were dispensed. Please understand that we do not regulate the practice of pharmacy and If you wish to learn about the regulation that governs what information must be provided by the pharmacy, please contact your respective <a href="https://nabp.pharmacy/boards-of-pharmacy/" target="_blank">state board of pharmacy</a>.</span></span></span></p><p></p><p><span style="font-family: 'Arial'"><span style="font-family: 'Arial'">Once you have the lot number, to find out if the losartan you take is part of the recall, please visit the following link, which lists losartan containing drugs with corresponding manufacturers and lot numbers that are affected by the recall at <a href="https://www.fda.gov/downloads/Drugs/DrugSafety/UCM628993.pdf" target="_blank">losartan medications under recall</a>. Losartan belongs to a drug class called angiotensin II receptor blocker (ARB). Please see the <span style="color: blue"><a href="https://www.fda.gov/Drugs/DrugSafety/ucm613916.htm" target="_blank">FDA updates on ARB recalls including valsartan, losartan, and Irbesartan</a> </span>webpage for the most up-to-date information. <span style="color: black">Please note that the FDA continues to investigate this matter and will post new information as it becomes available. Therefore, we recommend that you check our website frequently for updates and consult with your physician regarding any medical issue.</span></span></span></p><p></p><p></p><p><span style="font-family: 'Arial'"><span style="font-family: 'Arial'">You may also wish to view <span style="color: blue">the </span></span><span style="color: blue"><span style="font-family: 'Arial'"><a href="https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm629796.htm" target="_blank">Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research on the FDA’s ongoing investigation into valsartan and ARB class impurities and the agency’s steps to address the root causes of the safety issues</a> </span></span><span style="font-family: 'Arial'">for more information.</span></span></p><p></p><p><span style="font-family: 'Arial'"><span style="color: black"><span style="font-family: 'Arial'">For your future reference, please be advised that you may review the drug recall notices from our </span></span><span style="font-family: 'Arial'"><a href="https://www.fda.gov/Drugs/DrugSafety/DrugRecalls/default.htm" target="_blank">Drug Recalls</a><span style="color: black"> or </span><a href="https://www.fda.gov/Safety/Recalls/default.htm" target="_blank">Recalls, Market Withdrawals, & Safety Alerts</a><span style="color: black"> websites.</span></span></span></p><p></p><p><span style="font-family: 'Arial'"><span style="font-family: 'Arial'">We hope the information provided to you is helpful. If you have further questions, please do not hesitate to contact us again.</span></span></p><p><span style="font-family: 'Arial'"><span style="font-family: 'Arial'"></span></span></p><p><span style="font-family: 'Arial'"><span style="font-family: 'Arial'"></span></span></p><p><span style="font-family: 'Arial'"><span style="font-family: 'Arial'"></span></span> </p><p> So I called my pharmacy and they couldn't provide me with a lot # but they assured me my meds were not contaminated as it was a different brand than the recalled drug . For my own information I inquired why they couldn't provide me with a lot # and it's because they take meds out of multiple bottles and there is no way to know what lot # my prescription was filled from . </p><p></p><p> Then I looked again this morning at the FDA recall and it has been updated " <span style="color: #333333"><span style="font-family: inherit"> The recall is due to unacceptable amounts of N-Nitrosodiethylamine (NDEA) . I wish I would have taken a screenshot before the update just for the heck of it . </span></span></p><p><span style="color: #333333"><span style="font-family: inherit"></span></span></p><p><span style="color: #333333"><span style="font-family: inherit"> </span></span></p><p><span style="color: #333333"><span style="font-family: inherit"></span></span></p><p><span style="color: #333333"><span style="font-family: inherit"></span></span></p><p> Not sure how or why the contaminant changed overnight but it did, I suppose further testing. There are a lot of recalls on meds and most probably go unnoticed by consumers.</p></blockquote><p></p>
[QUOTE="Davy Crockett, post: 249994, member: 367"] I was digging for whatever information I could find on this kratom stuff and at the FDA website I noticed a recall on one of my meds due to traces of carcinogen (cancer causing agent) . There was no lot # on my container to confirm if mine was part of the recall or not so I emailed FDA a question . Me to FDA ~ "[FONT=Arial] I noticed a recent recall on Losartan due to possible [/FONT][FONT=Roboto][COLOR=#545454]carcinogen contamination and I see the affected lot # posted on your website but when I looked for the lot # on the packaging provided by my pharmacy I was surprised that there isn't one. Are we at the mercy of relying on our pharmacy to contact us about recalls or what is the safety procedure when recalls occur ?" FDA response~ " [/COLOR][/FONT] [FONT=Arial][COLOR=black][FONT=Arial]We greatly appreciate your time and effort in contacting the FDA to share your concern regarding the losartan drug recall. We understand your frustration with the limited information provided by your pharmacy. We recommend that you contact your pharmacy to obtain the lot number but we understand that if your medication was dispensed to you in the pharmacy’s container, then it may be difficult to track the lot number you were dispensed. Please understand that we do not regulate the practice of pharmacy and If you wish to learn about the regulation that governs what information must be provided by the pharmacy, please contact your respective [URL="https://nabp.pharmacy/boards-of-pharmacy/"]state board of pharmacy[/URL].[/FONT][/COLOR][/FONT] [FONT=Arial][FONT=Arial]Once you have the lot number, to find out if the losartan you take is part of the recall, please visit the following link, which lists losartan containing drugs with corresponding manufacturers and lot numbers that are affected by the recall at [URL="https://www.fda.gov/downloads/Drugs/DrugSafety/UCM628993.pdf"][COLOR=windowtext]losartan medications under recall[/COLOR][/URL]. Losartan belongs to a drug class called angiotensin II receptor blocker (ARB). Please see the [COLOR=blue][URL="https://www.fda.gov/Drugs/DrugSafety/ucm613916.htm"]FDA updates on ARB recalls including valsartan, losartan, and Irbesartan[/URL] [/COLOR]webpage for the most up-to-date information. [COLOR=black]Please note that the FDA continues to investigate this matter and will post new information as it becomes available. Therefore, we recommend that you check our website frequently for updates and consult with your physician regarding any medical issue.[/COLOR][/FONT][/FONT] [FONT=Arial][FONT=Arial]You may also wish to view [COLOR=blue]the [/COLOR][/FONT][COLOR=blue][FONT=Arial][URL="https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm629796.htm"]Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research on the FDA’s ongoing investigation into valsartan and ARB class impurities and the agency’s steps to address the root causes of the safety issues[/URL] [/FONT][/COLOR][FONT=Arial]for more information.[/FONT][/FONT] [FONT=Arial][COLOR=black][FONT=Arial]For your future reference, please be advised that you may review the drug recall notices from our [/FONT][/COLOR][FONT=Arial][URL="https://www.fda.gov/Drugs/DrugSafety/DrugRecalls/default.htm"]Drug Recalls[/URL][COLOR=black] or [/COLOR][URL="https://www.fda.gov/Safety/Recalls/default.htm"]Recalls, Market Withdrawals, & Safety Alerts[/URL][COLOR=black] websites.[/COLOR][/FONT][/FONT] [FONT=Arial][FONT=Arial]We hope the information provided to you is helpful. If you have further questions, please do not hesitate to contact us again. [/FONT][/FONT] So I called my pharmacy and they couldn't provide me with a lot # but they assured me my meds were not contaminated as it was a different brand than the recalled drug . For my own information I inquired why they couldn't provide me with a lot # and it's because they take meds out of multiple bottles and there is no way to know what lot # my prescription was filled from . Then I looked again this morning at the FDA recall and it has been updated " [COLOR=#333333][FONT='inherit'] The recall is due to unacceptable amounts of N-Nitrosodiethylamine (NDEA) . I wish I would have taken a screenshot before the update just for the heck of it . [/FONT][/COLOR] Not sure how or why the contaminant changed overnight but it did, I suppose further testing. There are a lot of recalls on meds and most probably go unnoticed by consumers. [/QUOTE]
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