US Drug Recall Register
Class II · Moderate risk Terminated Initiated Sep 17, 2013 (13 years ago)

Amlodipine Besylate Tablets, USP, 5 mg*, packaged in a) 100-count (10 x 10) unit dose…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

What was recalled

Amlodipine Besylate Tablets, USP, 5 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-451-20; b) 300-count (10 x 30) unit dose blisters per carton, NDC 51079-451-56, c) 25-count (25 x 1) Robot-Rx Ready Packages in a carton, NDC 51079-451-19; and d) 30-count tablets per dosage card in a carton, NDC 51079-451-69, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505; Packaged and Distributed By: UDL Laboratories, Inc., Rockford, IL 61103.

Recalling firm
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
NDC code
51079-451-20
Origin
IL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1467-2016

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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