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.

FDA recall notice · announced December 24, 2014 · Zydus Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Nationwide and Puerto Rico
Lot/code information: Lot #: MP2137, MP2138, MP2139, Exp 01/16; MP3614, Exp 03/16; MP5611, MP5613, Exp 05/16
Quantity: 58,920 bottles
Status: Terminated
Products in this recall event:
- 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 68 (D-0299-2015)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.