Analysis shows the prescription oral medication, used as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus, exceeded the Acceptable Daily Intake Limit for the impurity N-Nitrosodimethylamine (NDMA).
NDMA is classified as a probable human carcinogen (a substance that could cause cancer).
The firm has not received any reports of adverse events to date.
The following product, packaged in a bottle containing 60 tablets, is being recalled:
Product Name | NDC | Lot Number | Expiration Date |
|---|---|---|---|
| Metformin Hydrochloride Extended-Release Tablets USP, 500mg | 68180-336-07 | G901203 | 12/2020 |
It was shipped nationwide to wholesalers, distributors, and mail order pharmacies.
What to do
Patients taking the recalled medication should continue to do so and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment.
Consumers with questions may contact Inmar Rx Solutions at (855) 532-1856 Monday – Friday, 9:00 am to 5:00 pm (EST).