Friday, September 11, 2020 A team of experienced and committed journalists. September 23, 2020 -- 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 recall involves Riomet ER (500 mg per 5 mL), with Lot Number AB06381 and Expiration Date 10/2021. Distributors and retailers that have Riomet ER™ (metformin hydrochloride for extended release oral suspension), which is being recalled, should stop distributing and return it to place of purchase or as directed in the recall notification. By Quasa Thursday, September 24, 2020 Come. Marksans Pharma Limited in India is voluntarily expanding its earlier initiated recall in June to include an additional 76 lots of Metformin Hydrochloride Extended-Release Tablets, USP 500 mg. and 750 mg. to the consumer level. 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. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Date: 9/23/2020 . 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 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. By Quasa Thursday, September 24, 2020 Come. 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. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. 68180-336-07 (11/05/2018 — 05/22/2020) ... Lupin isn't the only company to recall Metformin this week, and they're the sixth company in all to do it. 1 Nashville; 2 Iggy Azalea; 3 Leslie West; 4 Wonder Woman 1984; 5 2020 Honda Accord; 6 Alvin Kamara; 7 Credit Report; 8 Morgan & Morgan; 9 K. C. Jones; 10 Andrew Kaczynski; Top Searches Holiday Gifts. Ranbaxy Metformin Product Recall (2020-02-26) Report a Concern. To date, SUN PHARMA has not received any reports of adverse events related to this recall. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Sun Pharma Issues Voluntary Nationwide Recall of Riomet ER™ (metformin HCl for ER oral suspension) due to NDMA . Marksans Pharma Limited, the manufacturer of Metmorfin, have expanded a recall initially announced in June that now includes an additional 76 unexpired lots of the medication. 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. Sun Pharma the latest to recall metformin after carcinogen tests come up positive - FiercePharma Once cleared by the FDA of a probable carcinogen, generic diabetes med metformin has now been the target of a growing number of recalls. Sun Pharma is voluntarily recalling 1 lot of Riomet ER™ (metformin hydrochloride [HCl] for extended -release [ER] oral suspension), 500 mg per 5 mL, to the consumer level. List of Metformin Recalls for High Levels of NDMA Carcinogens About this Recall: Sun Pharma is … By Dawn Geske 06/02/20 AT 10:35 AM. 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 … 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". Valuable and timely information on drug therapy issues impacting today's health care and pharmacy environment. Marksans expanded its voluntary recall to include 76 additional unexpired lots of metformin ER tablets (500 mg and 750mg) labeled as Time-Cap Labs. Pure Extracts Commences Study on Psilocybin Oral Tablets, Capsules and Nasal... Incyte and Cellenkos Enter into Development Collaboration Agreement for CK0804, Belarus Starts Vaccination with “Sputnik V” Vaccine. The product has been manufactured at Sun Pharma’s Mohali-based manufacturing plant and is being recalled by its U.S.-based subsidiary. Sun Pharma, meanwhile, has been facing manufacturing issues with its metformin products. 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. Aug 10, 2020 11:30am. We have created a site to share drug recall information. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox. Diabetes Drug Recall 2020: Another Metformin Medication Recalled Over Cancer Concerns. 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. The recalled drugs are marketed as “extended-release tablets” under the brand name Time-Cap Labs, Inc. Some lots of the diabetes medication metformin were placed under voluntary recall on Wednesday by U.S. distributor, Bayside Pharmaceuticals. 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. round bottle. 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. (473 mL) round bottle. Text. - 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 … NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. The product was distributed nationwide to wholesale customers. This week, a seventh drugmaker has joined the metformin recall parade after finding high levels of a potential … NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. Related: Sun Pharma recalls 1 lot of metformin due to NDMA levels 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. September 23, 2020 -- 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. 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. September 23, 2020 -- 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. Questions about the recall can be directed to Sun Pharmaceuticals at 1-800-818-4555, Monday through Friday from 8 a.m. to 5 p.m. EST or by email at drug.safetyUSA@sunpharma.com. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. 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. Both the companies are recalling metformin because it may contain N-nitrosodimethylamine … At Magellan Rx Management, we want to help you get the best possible care. Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Riomet ER™ (Metformin Hydrochloride for Extended-Release Oral Suspension) Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit, We comply with the HONcode standard for trustworthy health information -, https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-metformin, Riomet ER™ (metformin hydrochloride for extended-. Several other generic drugmakers were also asked to recall metformin products due to similar NDMA concerns last May. UPDATE: March 11, 2020. In the release the company stated the recalled lot represents 747 bottles with an expiration date of October 2021. 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