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
Recall Number: D-0325-2015
Firm: Zydus Pharmaceuticals USA Inc
Classification: Class II
Status: Terminated
Report Date: 20141231
Initiation Date: 20141223
Termination Date: 20170922
Reason for Recall
Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
Product Description
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