Drug product
Benzonatate Capsules, USP, 200 mg, 100-count bottles, Rx only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA, In, Pennington, NJ USA 08534; NDC 68382-248-01, UPC 3 68382 24801 5.
D-0299-2015
Product summary
- Event
- Event 69911
- Status
- Terminated
- Classification
- Class II
- Quantity
- 58,920 bottles
- Official record key
drug-enforcement:D-0299-2015
Official wording
Reason: Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
Code information: Lot #: MP2137, MP2138, MP2139, Exp 01/16; MP3614, Exp 03/16; MP5611, MP5613, Exp 05/16
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Unknown
Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.