Drug product
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.
D-1468-2016
Product summary
- Event
- Event 66393
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 11,064 cartons; b) 2,052 cartons; c) 5,567 cartons
- Official record key
drug-enforcement:D-1468-2016
Official wording
Reason: CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Code information: Lot #: a) 3039795, 3042896, Exp 04/14; b) 3039793, 3042892, Exp 04/14; c) 2120054, Exp 02/14; 2120090, Exp 05/14
Distribution pattern: Nationwide, Puerto Rico and Guam
Derived failure modes
-
Manufacturing or process control
CGMP Deviations