Consumers with questions regarding this recall can contact Sun Pharma by calling 1-800-818-4555 Monday through Friday between 8:00 am to 5:00 pm EST or e-mailing drug.safetyUSA@sunpharma.com. Available for Android and iOS devices. The affected Riomet ER™ is the following lot: The product can be identified by the bottles or carton labeled as Riomet ER™ (metformin hydrochloride for extended-release oral suspension), containing the specific Lot Number and Expiration Date referenced above or on the labeling below. The product has been manufactured at Sun Pharma’s Mohali-based manufacturing plant and is being recalled by its US-based subsidiary. Sun Pharmaceutical Industries, Inc., a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd. is voluntarily recalling one lot of RIOMET ER™ (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL to the consumer level. The reason for the recall is due to the level of N-Nitrosodimethylamine (NDMA), which has been found to be above the allowable Acceptable Daily Intake (ADI) limit established by the U.S. Food and Drug Administration. To date, SUN PHARMA has not received any reports of adverse events related to this recall. Aug 10, 2020 11:30am. Sun Pharmaceutical Industries is voluntarily recalling one lot of RIOMET ER (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL to the consumer level.. The reason for the recall is due to the level of N-. Text. 11 Oct 2020, 18:47; ... while the recall applies to metformin tablets between 500 mg and 750 mg. First Participants Dosed in Phase 3 Clinical Trial of Janssen’s COVID-19 Vaccine, Sanofi and GSK Sign Agreements with Canada to Supply up to 72M Doses of COVID-19 Vaccine, The UK Regulator Authorised the Oxford/AstraZeneca Vaccine, FDA Approves First Generic of Drug Used to Treat Severe Hypoglycemia, Requirements for the Functioning of Pharma Markets Were Reduced During the Pandemic. Trending. Diabetes Drug Recall 2020: Another Metformin Medication Recalled Over Cancer Concerns. UPDATE: March 11, 2020. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. Fearing microbial contamination, Sun Pharmaceutical Industries Ltd. has recalled two batches of its anti-diabetic drug Riomet (Metformin Hydrochloride Oral Solution). Sun Pharma has posted a lot recall of Riomet ER™ (metformin hydrochloride [HCl] for extended-release [ER] oral suspension). High levels of the probable carcinogen NDMA have been found in the U.S. supply of the widely used diabetes drug metformin, according to testing done by the online pharmacy … Patients taking Riomet ER™ (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. Sun Pharmaceutical Industries, Inc. (SUN PHARMA), a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd. is voluntarily recalling one lot of RIOMET ER™ (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL to the consumer level. Each carton contains one bottle of drug pellets, one bottle of diluent, and one dosing cup. Sun Pharmaceutical Industries Inc. Issues Voluntary Nationwide Recall of Riomet® (Metformin Hydrochloride Oral Solution) Manufactured by a Contract Manufacturer Due to Microbial Contamination We use cookies to ensure that we give you the best experience on our website. Metformin tablets are used to treat type 2 diabetes and are designed to lower glucose levels. The product was distributed nationwide to wholesale customers. There were metformin recalls in Singapore late last year and in Canada this month, but so far the U.S. hasn’t followed suit. BRAND COMPARISON: Glucophage XR® DESCRIPTION : Metformin Hydrochloride Extended-Release Tablets, 500 mg NDC# 62756-142-01 Dosage Form: Tablet Pack Type: Bottle Pack Size: 100 Rating : AB1 Color / Shape: White to Off-white / Capsule Shaped Therapeutic Category: Antidiabetic Agents Schedule: Rx Date: 9/23/2020 . "GMP news" is a Portal about international GMP Standard for pharmaceutical professionals and specialists, managers, and students. Sun Pharmaceutical Industries, Inc., a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd. is voluntarily recalling one lot of RIOMET ER™ (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL to the consumer level. According to CNN, ... 1 London Bridge Street, London, SE1 9GF. Both the companies are recalling metformin because it may contain N-nitrosodimethylamine … Select one or more newsletters to continue. 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). Date: 9/23/2020 . Sun Pharmaceutical Industries is voluntarily recalling one lot of RIOMET ER (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL to the consumer level.. The latest manufacturer to recall the prescription is Sun Pharma, which late last month, announced a voluntary recall of one lot of its extended-release (ER) metformin hydrochloride oral suspension (Riomet ER). (473 mL) round bottle. Riomet ER™ (metformin hydrochloride for extended-release oral suspension) is a prescription oral medication indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. Metformin – Safety update. Marksans expanded its voluntary recall to include 76 additional unexpired lots of metformin ER tablets (500 mg and 750mg) labeled as Time-Cap Labs. FDA Requests Metformin Recall by Five Drug Manufacturers The information provided on this Web site should not be construed as medical instruction. Recall of Riomet ER™ (metformin HCl for ER oral suspension) due to NDMA . September 23, 2020 - Sun Pharmaceuticals announced a voluntary, consumer-level recall of one lot of Riomet ER (metformin) extended release oral suspension due to the level of N-Nitrosodimethylamine (NDMA), which has been found to be above the allowable Acceptable Daily Intake (ADI) limit established by the FDA. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. Sun Pharma, meanwhile, has been facing manufacturing issues with its metformin products. PRINCETON, N.J.--(BUSINESS WIRE)-- Sun Pharmaceutical Industries, Inc. (SUN PHARMA), a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd. is voluntarily recalling one lot of RIOMET ER™ (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL to the consumer level.The reason for the recall is due to the level of N-Nitrosodimethylamine (NDMA), … RIOMET ER is a prescription oral medication indicated as an adjunct to diet and exercise to improve glycemic control in adults and paediatric patients 10 years of age and older with type 2 diabetes mellitus. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. Sun Pharmaceuticals – Recall of Riomet ER ™ (metformin). According to CNN, the recall applies to … The recall involves Riomet ER (500 mg per 5 mL), with Lot Number AB06381 and Expiration Date 10/2021. As per the USFDA, the company is recalling the product due to deviation from the current good manufacturing practices (CGMP) – detection of N-nitrosodimethylamine (NDMA) impurity in the finished drug product. To date (September 23, 2020), Sun Pharma reports it has not received any reports of adverse events related to this recall. According to the U.S. Food & Drug Administration, it could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their health care professionals. Each carton contains one bottle of drug pellets, one bottle of diluent, and one dosing cup. Metformin Hydrochloride Extended Release Tablets USP BRAND COMPARISON: Glumetza® DESCRIPTION : Metformin Hydrochloride Extended Release Tablets USP 500mg, 100 tablets NDC# 47335-305-88 Dosage Form: Tablet To date, Sun Pharma has not received any reports of adverse events related to this recall. - On 11 Mar 2020, the DH endorsed a licensed wholesale dealer, the International Medical Company Ltd, to recall 3 batches of Metformin-Teva 500mg Tablets (HK-60334) (batch number: 16532717, 16532817 and 16532917) from the market due … The reason for the recall is due to the level of N-Nitrosodimethylamine (NDMA), which has been found to be above … U.S. health regulators are telling five drugmakers to recall versions of the widely used diabetes medication after testing revealed elevated levels of a contaminant linked to cancer in several lots. In the release the company stated the recalled lot represents 747 bottles with an expiration date of October 2021. We have created a site to share drug recall information. On Oct. 9, 2020, the FDA provided an update to this recall to include two voluntary recalls by Marksans Pharma and Sun Pharmaceutical Industries for extended release metformin due to … Moderna and Recipharm Have Reached an Agreement to Supply Vaccine Outside... Czech Approve Squeezing Extra Dose from BioNTech/Pfizer Vaccine Vials, First Batch of “Sputnik V” Vaccine Arrives in Serbia. According to the U.S. Food & Drug Administration, it could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their health care professionals. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Sun Pharma which is the biggest Indian drug manufacturer by volume and the fourth largest generic drug producer in the world found the oral solution to be contaminated with Scopulariopsis brevicaulis. About this Recall: Sun Pharma is … Back in November 2017, the U.S. subsidiary carried out a nationwide voluntary recall of two lots of Riomet (metformin oral solution). To date, SUN PHARMA has not received any reports of adverse events related to this recall. Sun Pharmaceutical Industries, Inc., a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd. is voluntarily recalling one lot of RIOMET ER™ (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL to the consumer level. (473 mL) round bottle. The recall expands a previous recall issued November 2020. Sun Pharma is notifying its distributors and customers through its third-party Recall Coordinator (Inmar Inc.), via FedEx standard overnight shipping and will arrange for return of all recalled products. The US FDA is alerting patients and health care professionals to two voluntary recalls of extended release (ER) metformin by Marksans Pharma and Sun Pharmaceutical. If you continue to use this site we will assume that you are happy with it. Sun Pharma recalls 747 bottles of generic diabetes drug in US market: USFDA The US health regulator has classified it as a Class-II recall, which is initiated in a "situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote". RIOMET ER™, when reconstituted, is packaged in a 16 oz. Several other generic drugmakers were also asked to recall metformin products due to similar NDMA concerns last May. FDA Publish Date: 9/23/2020. Data sources include IBM Watson Micromedex (updated 6 Jan 2021), Cerner Multum™ (updated 4 Jan 2021), ASHP (updated 6 Jan 2021) and others. Experienced and committed journalists suspension ( 500 mg per 5 mL ), with lot Number AB06381 Expiration... At Magellan Rx Management, we want to help you get the best on. 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