A voluntary recall of twenty-three lots of Metformin Hydrochloride Extended-Release Tablets was initiated by Viona Pharmaceuticals Inc. As stated in the FDA recall notice, the company is recalling the lots at the consumer level out of an “abundance of caution” after N-nitrosodimethylamine (NDMA), a known carcinogen, was observed in one lot of the product lots (M008132) during testing. To date, neither the company nor the manufacturer, Cadila Healthcare Limited, has received any negative reports related to this recall.
The drug is used, in conjunction with diet and exercise, to control high blood sugar in patients with type 2 diabetes mellitus. Failure to regulate blood glucose can lead to kidney damage, blindness, nerve damage, loss of limbs, as well as sexual challenges. Patients currently on a medicinal protocol that includes the ingestion of Metformin are encouraged by the FDA to continue taking the tablets and immediately call their physician to request an alternative medication, as abruptly stopping the use of the Metformin may lead to health complications.
The probable human carcinogen NDMA is listed as an environmental contaminant by the FDA, and is known to infect water and foods, including but not limited to meat, dairy, and vegetables. According to DrugWatch, NDMA is a “yellow, odorless, liquid chemical” typically used to make rocket fuel, and is also a byproduct of manufacturing processes and water chlorination. Overexposure to NDMA can cause side effects such as headache, fever, nausea, jaundice, vomiting, abdominal cramps, an enlarged liver, dizziness, and reduced liver, kidney, and lung function. Although more research is needed, researchers reported that NDMA caused liver and lung cancer in animal studies.
The recalled lots of Metformin Hydrochloride Extended-Release Tablets (USP 750 mg) are white to off-white, capsule-shaped, uncoated tablets, with “Z”, “C” on one side and “20” on the other side. The product was distributed nationwide. A full list of the recalled lots may be found at fda.gov/safety.
Customers are currently being notified by Viona Pharmaceuticals Inc. via mail and email. The return of the recalled product is being arranged by the company. Consumers are being urged to send the product to Inmar Pharmaceuticals Services-Recalls, 3845 Grand Lakes Way, Grand Prairie, Texas 75050. The company’s recall processing center may be contacted Monday through Friday from 9:00 am to 5:00 pm (EST) at 1-855-249-3303. If individuals wish to report adverse events related to this recall, they may call Viona Pharmaceuticals Inc. at 888-304-5011, Monday through Friday from 8:30 am to 5:30 pm (EST). Negative reactions may also be reported directly to the FDA online or by calling 1-800-332-1088 to request a report form.
Call A Dangerous Drug Lawyer
When an individual ingests a medication in order to improve their health, they expect the drug to be effective and not cause further damage to their health. Unfortunately, this is not always the case. Dangerous drug litigation is complex and requires expertise and experience, as well as a detailed understanding of the particular product that is the subject of litigation. The personal injury law firm of Panter, Panter & Sampedro has successfully pursued dangerous and defective drug claims on behalf of individuals injured by pharmaceuticals. Speak to a dangerous drug attorney today by calling us at (305) 662-6178.
Sources:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/viona-pharmaceuticals-inc-issues-voluntary-nationwide-recall-metformin-hcl-extended-release-tablets-0
https://www.drugwatch.com/health/cancer/ndma/
