Recall: D-1134-2017

Class III - Minor Violations

Class IIIClassification

2017-05-05Initiated

TerminatedStatus

Ascend Laboratories LLCFirm

Product

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

Reason

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.

Distribution

Nationwide in the USA.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.