Amlodipine Besylate Tablets, USP, 10 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-452-20; b) 300-count (10 x 30) unit dose blisters per carton, NDC 51079-452-56; and c) 25-count (25 x 1) Robot-Rx Ready Packages in a carton, NDC 51079-452-19; Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505; Packaged and Distributed By: UDL Laboratories, Inc., Rockford, IL 61103.
Hazard
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
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Products
Amlodipine Besylate Tablets, USP, 10 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-452-20; b) 300-count (10 x 30) unit dose blisters per carton, NDC 51079-452-56; an
- Brand
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- UPC
- Lot #: a) 3039795, 3042896, Exp 04/14; b) 3039793, 3042892, Exp 04/14; c) 2120054, Exp 02/14; 2120090, Exp 05/14
Units Affected
a) 11,064 cartons; b) 2,052 cartons; c) 5,567 cartons