Drug product
Amlodipine Besylate Tablets, USP 10 mg, Rx Only, 90 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-123-16
D-0257-2015
Product summary
- Event
- Event 69676
- Status
- Terminated
- Classification
- Class III
- Quantity
- 15,144 bottles
- Official record key
drug-enforcement:D-0257-2015
Official wording
Reason: Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344.
Code information: Lot #: MP4344, Exp 04/2016
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344.