Class II
Terminated
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.
This recall has been terminated (originally issued August 31, 2016).
- Recall Initiated
- September 17, 2013
- Posted
- August 31, 2016
- Recall Number
- D-1466-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- a) 9,156 cartons; b) 521,310 cartons
- Firm Location
- Rockford, IL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Distribution
Nationwide, Puerto Rico and Guam
Lot / Code Info
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
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