FDA-Drug2014-12-24Class II

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.

Zydus Pharmaceuticals USA Inc
Hazard

Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.

Sold states
Nationwide and Puerto Rico
Affected count
58,920 bottles
Manufactured in
73 Route 31 N, N/A, Pennington, NJ, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0299-2015

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