hcinfo.infosc@canada.ca, Health Canada evaluating NDMA in metformin drugs, Health Canada updates Canadians on its ongoing assessment of nitrosamine impurities in certain drugs, Multiple recalls of ranitidine drugs; request to stop distribution remains in place while Health Canada continues to assess NDMA, Impurities found in certain angiotensin II receptor blocker (ARB) products, also known as sartans, APO-Metformin ER (Metformin Hydrochloride Extended-Release Tablets), APO-METFORMIN ER (Metformin Hydrochloride Extended-Release Tablets). Metformin Extended Release 500mg and 750mg Recall – Amneal Pharmaceuticals LLC. In the 500-count bottles, the recalled Metformin carries the NDC No. Smart Grocery Shopping When You Have Diabetes, Surprising Things You Didn't Know About Dogs and Cats, Coronavirus in Context: Interviews With Experts, Sign Up to Receive Our Free Coroanvirus Newsletter, Images of Diabetic Retinopathy and Other Vision Problems. On September 23, 2020, Sun Pharmaceuticals recalled a single lot of RIOMET ER, metformin hydrochloride for extended release oral suspension (500 mg per 5 mL). Starting date: June 12, 2020. Should any additional recalls be necessary, Health Canada will update the table below and inform Canadians. Metformin is a prescription drug used to control high blood sugar in patients with type 2 diabetes. On May 28th the FDA recommended a recall of metformin ER products from 5 manufacturers (Apotex Corp, Actavis/Teva Pharmaceuticals, Amneal, and Time-Cap Labs Inc./Marksans Pharma limited, Sun Pharma’s Riomet Metformin oral suspension) due to unacceptably high levels of a chemical called N-nitrosodimethylamine (NDMA). of 70010-492-05 with a lot and expiration date of 4920005B/Jun-21. APO-Metformin (2020-06-12) Report a Concern. This medication is being recalled due to an impurity, NDMA, that has been identified as a possible carcinogen (a substance that could cause cancer). Type of communication: Drug Recall. Company Contact: Ms. Candis Edwards. Ask your pharmacist if you are unsure whether you are taking a recalled product. By Editor. The recall includes 100- and 500-count bottles of 750 mg metformin tablets. These include heart disease, nerve problems, kidney damage, blindness and amputations. As a precautionary measure, the company is also recalling eight other lots because levels of NDMA in those products may increase over time. Health Canada continues to work closely with international regulatory partners to address the issue. TRICARE Home Delivery - Avkare Metformin Extended-Release Tablets Recall Notice June 25, 2020 If you filled Metformin extended-release tablets 500mg or 750mg through TRICARE Home Delivery between 02/01/2020 – 06/01/2020, please review the letter communication sent to beneficiaries about the details of the recall: Avkare Metformin Recall Letter In a new update on June 11, the FDA said that Lupin Pharmaceuticals has voluntarily recalled a single lot of its metformin hydrochloride extended-release tablets in … The recall for all lots of metformin hydrochloride extended-release tablets 500 mg from Apotex comes after one lot tested by the U.S. Food and Drug Administration had higher NDMA levels than allowed by the FDA. The product was available in 60-, 90-, and 100-count bottles. FOR IMMEDIATE RELEASE – June 3, 2020 - Amneal Pharmaceuticals LLC Bridgewater, New Jersey (Amneal), is voluntarily recalling all lots of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, within expiry to the Consumer Level.. Amneal was notified by the … Amneal’s Metformin Hydrochloride Immediate Release Tablets are not affected by this recall. Apotex Inc. is voluntarily recalling nine additional lots of its prescription metformin drug, APO-METFORMIN ER (extended release) 500mg tablets. To assist you in the care of your patients, we want to alert you to the drug recall of metformin extended-release (ER) products effective June 1, 2020. email: Information@amneal.com. Joseph June 25, 2020 at 4:08 pm Reply. High blood sugars. There are also alternative metformin products on the Canadian market manufactured by other companies. Symptoms of high blood sugars include increased urination, thirst, excessive hunger, fatigue, blurred vision, drowsiness, irritability, unintended weight loss and dizziness. Very high blood sugars can lead to effects such as vomiting, diarrhea, dehydration, confusion, agitation and coma. Published June 21, 2020 In June 2020, there were announcements about recalls of metformin and some related medications by both Apotex Corp and Amneal Pharmaceuticals. Stopping the metformin is more dangerous than the contaminant. Please inform your patients of the possible problem and consider clinically … Nostrum Labs expands metformin drug recall January 5th, 2021. 1,2 We recommend you review your medical records and contact all patients for whom you prescribed metformin extended-release products. hc.media.sc@canada.ca, Public Enquiries: This image made available by the U.S. Food and Drug Administration on Thursday, May 28, 2020 shows a label for the drug metformin. Metformin Recalled for Possible Cancerous Chemical June 1, 2020 -- A recall of the widely-used diabetes drug metformin was announced by drug maker Apotex, due to possible … The Department asked companies to test their metformin products and is conducting testing in its own laboratories. Drug recall notice for metformin extended-release tablets . It was distributed by Time-Cap Labs, Inc. On June 5, 2020, Teva Pharmaceuticals recalled 14 lots of Metformin Extended-Release KE. Company testing identified two lots (#AJY8006A and #AJY8007A) with levels of NDMA above what is considered acceptable if the drug were to be taken over a lifetime. Numerous reports indicate that other manufacturers are set to potentially follow suit. What to do:You should not stop taking your metformin drug without first discussing options with your health care provider. If I were on extended release metformin, I'd ask my pharmacist to replace the recalled brand of pills if possible. Talk to your health care provider to discuss treatment options if you are taking a recalled product or if you have taken a recalled product and are concerned about your health. The risks from not having adequate diabetes treatment outweigh any possible effects of exposure to the levels of nitrosamines found in the recalled Apotex metformin products. Regardless, I'd carry on on taking the metformin and ask my doctor at my next visit what he thinks I should do. June 06, 2020 01:42 PM, ORDER REPRINT → Three makers of Type 2 diabetes drug Metformin announced recalls Friday, the U.S. Food & Drug Administration reported. they got ne up to … Company test results showed one of the lots (PY7174) contains a nitrosamine impurity called N-nitrosodimethylamine (NDMA) that increased over time to a level above the acceptable limit. 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