Drug product
Amlodipine besylate tablets, USP 2.5mg, packaged in 10-count blisters (NDC 68084-498-11); 10 blister packs per carton (NDC 68084-498-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.
D-1218-2015
Product summary
- Event
- Event 71553
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,896 cartons
- Official record key
drug-enforcement:D-1218-2015
Official wording
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints.
Code information: Lot #: 131924, Exp 07/31/2015
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations