{"id":11952,"date":"2020-06-02T09:55:49","date_gmt":"2020-06-02T13:55:49","guid":{"rendered":"https:\/\/www.singlecare.com\/blog\/?p=11952"},"modified":"2021-01-13T11:44:18","modified_gmt":"2021-01-13T16:44:18","slug":"metformin-recall-fda","status":"publish","type":"post","link":"https:\/\/www.singlecare.com\/blog\/news\/metformin-recall-fda\/","title":{"rendered":"FDA recalls metformin extended-release tablets"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">Metformin is a prescription medication commonly used to treat high blood sugar caused by prediabetes or Type 2 diabetes. In addition to being a diabetes drug, it\u2019s sometimes used as an <\/span><a href=\"https:\/\/www.singlecare.com\/blog\/off-label-prescription-drugs\/\"><span style=\"font-weight: 400;\">off-label<\/span><\/a><span style=\"font-weight: 400;\"> treatment option for <\/span><a href=\"https:\/\/www.singlecare.com\/blog\/metformin-for-pcos\/\"><span style=\"font-weight: 400;\">polycystic ovary syndrome<\/span><\/a><span style=\"font-weight: 400;\"> (PCOS). On Thursday, May 28, 2020, the <\/span><a href=\"https:\/\/www.fda.gov\/safety\/recalls-market-withdrawals-safety-alerts\/apotex-corp-issues-voluntary-nationwide-recall-metformin-hydrochloride-extended-release-tablets#recall-announcement\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">United States Food and Drug Administration<\/span><\/a><span style=\"font-weight: 400;\"> (FDA) issued a voluntary recall notice for the extended-release formulation of metformin 500 mg tablets, produced by Apotex and four other pharmaceutical companies.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">On Jan. 4, 2021, the FDA announced that the recall extends to additional manufacturers, forms, and dosages. <\/span><a href=\"https:\/\/www.fda.gov\/drugs\/drug-safety-and-availability\/search-list-recalled-metformin-products\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">Eleven companies<\/span><\/a><span style=\"font-weight: 400;\"> have now voluntarily withdrawn 500 mg, 750 mg, and 1000 mg extended-release metformin tablets and extended-release metformin oral suspension:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Amneal Pharmaceuticals<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Apotex Corp<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">AVKARE Inc. (Amneal)<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Bayshore Pharmaceuticals, LLC<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Denton Pharma, Inc. (Marksans)<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Direct Rx (Marksans)<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Granules Pharmaceuticals<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Lupin Pharmaceuticals<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Marksans Pharma Limited<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Nostrum Laboratories, Inc.<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">PD-Rx Pharmaceuticals (Amneal)<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">PD-Rx Pharmaceuticals (Marksans)<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Preferred Pharmaceuticals, Inc. (Marksans)<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">RemedyRepack Inc. (Marksans)<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Sun Pharmaceuticals Industries, Inc.<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Teva Pharmaceuticals<\/span><\/li>\n<\/ul>\n<h2><span style=\"font-weight: 400;\">Why is metformin ER being recalled?<\/span><\/h2>\n<p><a href=\"https:\/\/www.singlecare.com\/prescription\/metformin-hcl-er\"><span style=\"font-weight: 400;\">Metformin ER<\/span><\/a><span style=\"font-weight: 400;\"> is being recalled because testing found levels of nitrosamine impurity, called N-Nitrosodimethylamine (NDMA), that are above the intake limit designated safe by the FDA. The agency has been aware of trace impurities since late 2019, but further examination only recently revealed more significant amounts.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">NDMA is the same carcinogen that led to the <\/span><a href=\"https:\/\/www.singlecare.com\/blog\/news\/pharmacies-pull-zantac-ranitidine-recall\/\"><span style=\"font-weight: 400;\">recall of ranitidine<\/span><\/a><span style=\"font-weight: 400;\"> (often known by its brand name: Zantac) earlier this year. It\u2019s a common contaminant in water and grilled or cured meats. In other words, most people are exposed to low levels of NDMA. NDMA can enter drugs during the manufacturing, packaging, or storage process. It\u2019s suspected that long-term exposure to more significant amounts can be dangerous\u2014leading to symptoms like jaundice, nausea, fever, and ultimately <\/span><a href=\"https:\/\/www.atsdr.cdc.gov\/toxprofiles\/tp141-c1.pdf\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">liver damage or lung cancer<\/span><\/a><span style=\"font-weight: 400;\">.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u201cWe recalled one lot of metformin hydrochloride extended-release tablets, after the U.S. FDA tested it and showed results for N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI),\u201d Jordan Berman, Apotex Vice President, Global Corporate Affairs, Transformation &amp; Strategy, told SingleCare. \u201cOut of an abundance of caution, we extended the recall to all lots of metformin hydrochloride extended-release tablets in the US. Apotex stopped selling this product in the U.S. in February 2019, and there remains only limited product on the market. To date, we have not received any reports of adverse events related to use of the product.\u201d<\/span><\/p>\n<p><b>RELATED: <\/b><a href=\"https:\/\/www.singlecare.com\/blog\/metformin-side-effects\/\"><b>Metformin side effects and how to avoid them<\/b><\/a><\/p>\n<h2><span style=\"font-weight: 400;\">What to do if you take metformin ER<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">You should keep taking metformin ER until you speak to your healthcare provider about a replacement medication. It can be dangerous to stop using this medication abruptly\u2014especially when the risk associated with the metformin recall is fairly low.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u201cNow that we have identified some metformin products that do not meet our standards, we\u2019re taking action,\u201d said Patrizia Cavazzoni, MD, acting director of the FDA\u2019s Center for Drug Evaluation and Research in a <\/span><a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-alerts-patients-and-health-care-professionals-nitrosamine-impurity-findings-certain-metformin\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">statement<\/span><\/a><span style=\"font-weight: 400;\">. \u201cAs we have been doing since this impurity was first identified, we will communicate as new scientific information becomes available and will take further action, if appropriate.\u201d<\/span><\/p>\n<p><b>RELATED: <\/b><a href=\"https:\/\/www.singlecare.com\/blog\/what-to-do-when-a-drug-is-recalled\/\"><b>What to do if your medication is recalled<\/b><\/a><\/p>\n<h2><span style=\"font-weight: 400;\">What are the alternatives?<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">The metformin recall does not apply to immediate-release (IR) formulations, the most commonly prescribed kind of metformin, according to the FDA. Both medications are equally effective, and <\/span><a href=\"https:\/\/www.singlecare.com\/prescription\/metformin-hcl\"><span style=\"font-weight: 400;\">metformin IR<\/span><\/a><span style=\"font-weight: 400;\"> may even be less expensive. <\/span><span style=\"font-weight: 400;\">The main difference is that you may need to take metformin IR more often per day.<\/span><\/p>\n<p><b>RELATED: <\/b><a href=\"https:\/\/www.singlecare.com\/blog\/metformin-vs-metformin-er\/\"><b>Metformin vs. Metformin ER<\/b><\/a><\/p>\n<p><span style=\"font-weight: 400;\">Just remember to consult with your doctor or pharmacist before making a change. There are options available, but it\u2019s only safe to switch medications under the supervision of a healthcare provider.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Metformin is a prescription medication commonly used to treat high blood sugar caused by prediabetes or Type 2 diabetes. In addition to being a diabetes drug, it\u2019s sometimes used as an off-label treatment option for polycystic ovary syndrome (PCOS). On Thursday, May 28, 2020, the United States Food and Drug Administration (FDA) issued a voluntary [&hellip;]<\/p>\n","protected":false},"author":85,"featured_media":9067,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[4589,4114],"tags":[10298,72],"coauthors":[8869],"class_list":["post-11952","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-drug-info","category-news","tag-diabetes","tag-fda","wpautop"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.4 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Metformin recall by FDA: What\u2019s the latest news on metformin ER?<\/title>\n<meta name=\"description\" content=\"In May 2020, the FDA issued a voluntary recall notice for metformin ER 500 mg tablets. 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