Marksans Pharma Limited, India, is recalling Metformin Hydrochloride Extended-Release Tablets.
The product, used as an adjunct to diet and exercise to improve blood sugar control in adults and pediatric patients with type 2 diabetes mellitus, showed test results for N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI).
NDMA is classified as a probable human carcinogen (a substance that could cause cancer)
There are no reports of adverse events.
The following product, which is white to off white, capsule shaped, biconvex tablet, debossed with ‘101’ on one side and plain on the other side, and packaged in 100-count bottles with NDC code 49483-623-01, is being recalled:
- Metformin Hydrochloride Extended Release Tablets USP, 500 mg, Lot #: XP9004, Expiry Date (MM/YYYY): 12/2020
The recalled product was distributed by Time-Cap Labs nationwide to wholesalers who further distributed it to pharmacies.
What to do
Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
Consumers with questions regarding this recall and return may contact Irene McGregor of Time-Cap Labs at (631) 753-9090; ext. 160, Monday – Friday, 8am – 5pm (EST), or by e-mail at firstname.lastname@example.org.