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FDAMay 5, 2017drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

ascend laboratoriesascend

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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