Ascend Laboratories LLC recalls Metformin Hydrochloride Tablets, USP 500 mg, 1000 tablets, Rx Only Manufactured by: Alkem Laboratories Ltd., Mumbai - 4…

Recall date

November 2, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0163-2017

FDA classification

Class II

Brand / firm

Ascend Laboratories LLC

Sold / distributed

AL, FL, GA, SC & TN

Why it was recalled

Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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