Metformin Hydrochloride Tablets, USP 500 mg, 1000 tablets, Rx Only Manufactured by: Alkem Labora...
FDA Recall #D-0163-2017 — Class II — November 2, 2016
Product Description
Metformin Hydrochloride Tablets, USP 500 mg, 1000 tablets, Rx Only Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Montvale, NJ NDC 67877-217-10
Reason for Recall
Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP
Recalling Firm
Ascend Laboratories LLC — Montvale, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1739 bottles
Distribution
AL, FL, GA, SC & TN
Code Information
Lot 6121056, exp 5/2019
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated