Recalls / Class II
Class IID-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.
- Affected lot / code info
- Lot #: MP2137, MP2138, MP2139, Exp 01/16; MP3614, Exp 03/16; MP5611, MP5613, Exp 05/16
Why it was recalled
Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
Recalling firm
- Firm
- Zydus Pharmaceuticals USA Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 73 Route 31 N, N/A, Pennington, New Jersey 08534-3601
Distribution
- Quantity
- 58,920 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2014-11-26
- FDA classified
- 2014-12-16
- Posted by FDA
- 2014-12-24
- Terminated
- 2017-09-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0299-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.