Ascend Laboratories LLC recalls AMLODIPINE BESYLATE TABLET, USP, 10 mg, 1000 count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai -…

Recall date

May 5, 2017

Source

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

Recall number

D-1134-2017

FDA classification

Class III

Brand / firm

Ascend Laboratories LLC

Sold / distributed

Nationwide in the USA.

Why it was recalled

PRESENCE OF FOREIGN TABLETS/CAPSULES: A 2.5 mg Amlodipine Besylate tablet was found co-mingled with 10 mg Amlodipine Besylate tablets in a bottle labeled as Amlodipine Besylate 10 mg.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

AMLODIPINE BESYLATE TABLET, USP, 10 mg, 1000 count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC Montvale, NJ 07645, NDC 67877-199-10