Recalls / Class II
Class IID-0325-2015
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
- Brand name
- Benzonatate
- Generic name
- Benzonatate
- Active ingredient
- Benzonatate
- Route
- Oral
- NDCs
- 68382-091, 68382-247
- FDA application
- ANDA040597
- Affected lot / code info
- Lot #: MP2625, MP2626, MP2627 Exp 2/16; MP4875, MP4876, MP4877, MP4878 Exp 4/16; MP6482, MP6483, MP6484, MP6493, MP6494 Exp 6/16
Why it was recalled
Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
Recalling firm
- Firm
- Zydus Pharmaceuticals USA Inc
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 73 Route 31 N, Pennington, New Jersey 08534-3601
Distribution
- Quantity
- 19,536 units
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-12-23
- FDA classified
- 2014-12-23
- Posted by FDA
- 2014-12-31
- Terminated
- 2017-09-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0325-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.