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