FDA recall D-0299-2015

Product

Benzonatate Capsules, USP, 200 mg, 100-count bottles, Rx only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA, In, Pennington, NJ USA 08534; NDC 68382-248-01, UPC 3 68382 24801 5.

Reason for recall

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

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2014-11-26

Report date

2014-12-24

Termination date

2017-09-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pennington, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0299-2015