What’s the Problem?
This recall affects 1 lot (747 cartons) of RIOMET ER (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL to the consumer level, according to the U.S. Food & Drug Administration (FDA). The packaging of affected products contain the NDC Number 10631-019-17 and an Expiration Date of 10/2021.
Sun Pharmaceutical issued the recall after routine testing by the FDA identified NDMA levels above the allowable Acceptable Daily Intake (ADI).
“NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests,” FDA said. “NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.”
RIOMET ER is a prescription drug used to improve glycemic control in patients with type 2 diabetes mellitus. The recalled products is packaged in a 16 oz. (473 mL) round bottle, FDA said. Each carton contains one bottle of drug pellets, one bottle of diluent, and one dosing cup.
If you were prescribed any Riomet that is affected by this recall, you should contact your healthcare provider immediately regarding an alternative treatment. FDA is advising patients to continue taking Riomet until prescribed another diabetes medication, as quitting could result in adverse health consequences.
This recall began on September 23, 2020.
Do I Have a Riomet Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Riomet Lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
If you or a loved one was harmed by a recalled metformin drug, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.