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.
Reported: December 24, 2014 Initiated: November 26, 2014 #D-0299-2015
Product Description
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.
Details
- Recalling Firm
- Zydus Pharmaceuticals USA Inc
- Units Affected
- 58,920 bottles
- Distribution
- Nationwide and Puerto Rico
- Location
- Pennington, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Zydus Pharmaceuticals USA Inc. Units affected: 58,920 bottles.
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 24, 2014. Severity: Moderate. Recall number: D-0299-2015.
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