Metformin HCl Extended Release Tablets USP 500 mg, Generic for : Glucophage XR, Pkg Size 100, Mfg: Time-Cap Labs, Inc.; Farmingdale, NY, NDC #: 68788-6932-1, Preferred Pharmaceuticals, Inc.

FDA recall notice · announced November 25, 2020 · Preferred Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Metformin HCl Extended Release Tablets USP 500 mg, Generic for : Glucophage XR, Pkg Size 100, Mfg: Time-Cap Labs, Inc.; Farmingdale, NY, NDC #: 68788-6932-1, Preferred Pharmaceuticals, Inc.

Reason for recall

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.

Notes

Distribution: Distributed to two physician's offices located in FL.
Lot/code information: E0620F, Exp.12/31/2021; G2020M Exp., 04/30/2022
Quantity: 99 bottles (9990 Extended Release Tablets)
Status: Terminated
Products in this recall event:
- Metformin HCl Extended Release Tablets USP 500 mg, Generic for : Glucophage XR, Pkg Size 100, Mfg: Time-Cap Labs, Inc.; Farmingdale, NY, NDC #: 68788-6932-1, Preferred Pharmaceuticals, Inc. (D-0077-2021)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.