Reported Dec 3, 2014 · Terminated

Amlodipine Besylate Tablets, USP 10 mg, Rx Only, 90 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd.…

Zydus Pharmaceuticals USA Inc.

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: Zydus Pharmaceuticals USA Inc · 73 Route 31 N · Pennington, NJ · 08534-3601

Is this the product you have?

  • Amlodipine Besylate Tablets, USP 10 mg, Rx Only, 90 Tablets per bottle
  • Manufactured byCadila Healthcare Ltd. Ahmedabad, India
  • Distributed byZydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-123-16
Lot codes and dates
    • Lot #: MP4344
    • Exp 04/2016
Amount recalled
15,144 bottles

Where it was sold

  • Nationwide

Why it was recalled

Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344.

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 Feb 26, 2016 · Data as of Sep 19, 8:05 PM UTC

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