Drug product
Benzonatate Capsules, USP, 100 mg, Rx only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA, In, Pennington, NJ USA 08534; 100-bottle capsules - NDC 68382-247-01 500-bottle capsules - NDC 68382-247-05
D-0325-2015
Product summary
- Event
- Event 70101
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19,536 units
- Official record key
drug-enforcement:D-0325-2015
Official wording
Reason: Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
Code information: Lot #: MP2625, MP2626, MP2627 Exp 2/16; MP4875, MP4876, MP4877, MP4878 Exp 4/16; MP6482, MP6483, MP6484, MP6493, MP6494 Exp 6/16
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.