Recall: D-0325-2015

Class II - Potentially Harmful

Class IIClassification

2014-12-23Initiated

TerminatedStatus

Zydus Pharmaceuticals USA IncFirm

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

Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.

Distribution

Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.