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.
Recall initiated: 20201101
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated