PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: August 31, 2016 Initiated: September 17, 2013 #D-1467-2016

Product Description

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.

Reason for Recall

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

Details

Units Affected
a) 42,733 cartons; b) 3,267 cartons; c) 10,303 cartons; d) 4,262,856 cartons
Distribution
Nationwide, Puerto Rico and Guam
Location
Rockford, IL

Frequently Asked Questions

What product 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.. Recalled by Mylan Institutional, Inc. (d.b.a. UDL Laboratories). Units affected: a) 42,733 cartons; b) 3,267 cartons; c) 10,303 cartons; d) 4,262,856 cartons.
Why was this product recalled? ▼
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 31, 2016. Severity: Moderate. Recall number: D-1467-2016.

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