Drug product
Amlodipine Besylate Tablets, USP, 2.5 mg*, packaged in a)100-count (10 x 10) unit dose blisters per carton, NDC 51079-450-20 and b) 30-count tablets per dosage card in a carton, NDC 51079-450-63, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505; Packaged and Distributed By: UDL Laboratories, Inc., Rockford, IL 61103.
D-1466-2016
Product summary
- Event
- Event 66393
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 9,156 cartons; b) 521,310 cartons
- Official record key
drug-enforcement:D-1466-2016
Official wording
Reason: CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Code information: Lot #: a) 3039792, Exp 04/14; 3037880, Exp 01/14; 3043938, Exp 07/14; b) 3036811, Exp 10/13; 3037514, Exp 01/14; 3039975, Exp 04/14; 3042583, Exp 07/14
Distribution pattern: Nationwide, Puerto Rico and Guam
Derived failure modes
-
Manufacturing or process control
CGMP Deviations