FDA recall D-0325-2015

Zydus Pharmaceuticals USA Inc · Class II · 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

Reason for recall

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

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2014-12-23
Report date: 2014-12-31
Termination date: 2017-09-22
Voluntary/Mandated: Voluntary: Firm initiated
Location: Pennington, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0325-2015