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
Reported: December 31, 2014 Initiated: December 23, 2014 #D-0325-2015
Product Description
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.
Details
- Recalling Firm
- Zydus Pharmaceuticals USA Inc
- Units Affected
- 19,536 units
- Distribution
- Nationwide
- Location
- Pennington, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Zydus Pharmaceuticals USA Inc. Units affected: 19,536 units.
Why was this product recalled? ▼
Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 31, 2014. Severity: Moderate. Recall number: D-0325-2015.
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