Reported Sep 20, 2017 · Terminated

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

Ascend Laboratories LLC

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Ascend Laboratories LLC · 180 Summit Ave Ste 200 · Montvale, NJ · 07645-1722

Is this the product you have?

  • AMLODIPINE BESYLATE TABLET, USP, 10 mg, 1000 count bottle, Rx Only
  • Manufactured byAlkem Laboratories Ltd., Mumbai - 400 013, India
  • Distributed byAscend Laboratories, LLC Montvale, NJ 07645, NDC 67877-199-10
Lot codes and dates
    • Lot #: 6142626
    • Exp 09/19
Amount recalled
1212 bottles

Where it was sold

  • Nationwide

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.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Apr 25, 2018 · Data as of Sep 19, 5:07 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.