drugs Class II Updated 2014-12-31

Zydus Pharmaceuticals USA Inc recalls Benzonatate Capsules, USP, 100 mg, Rx only, Manufactured by

Recalled 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

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
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
View official government recall

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