Drug recall D-0325-2015
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
Reason for recall
Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
Lots and codes
Lot #: MP2625, MP2626, MP2627 Exp 2/16; MP4875, MP4876, MP4877, MP4878 Exp 4/16; MP6482, MP6483, MP6484, MP6493, MP6494 Exp 6/16
Recall details
- Recalling firm
- Zydus Pharmaceuticals USA Inc, Pennington, NJ
- Quantity
- 19,536 units
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- December 23, 2014
- Terminated
- September 22, 2017
Related products
- Benzonatate – drug information
- NDC 68382-091 Benzonatate · Benzonatate 200 mg/1 · Zydus Pharmaceuticals USA Inc.
- NDC 68382-247 Benzonatate · Benzonatate 100 mg/1 · Zydus Pharmaceuticals USA Inc.