Metformin HCl Extended Release Tablets USP 500 mg, Generic for : Glucophage XR, Pkg Size 100, Mfg...
FDA Recall #D-0077-2021 — Class II — November 1, 2020
Product Description
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.
Recalling Firm
Preferred Pharmaceuticals, Inc. — Anaheim, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
99 bottles (9990 Extended Release Tablets)
Distribution
Distributed to two physician's offices located in FL.
Code Information
E0620F, Exp.12/31/2021; G2020M Exp., 04/30/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated