FDAClass IIDecember 24, 2014

Benzonatate Capsules recall

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.

Why was Benzonatate Capsules recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: MP2137, MP2138, MP2139, Exp 01/16; MP3614, Exp 03/16; MP5611, MP5613, Exp 05/16

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.
Recalling firm
Zydus Pharmaceuticals USA Inc
Quantity
58,920 bottles
Distribution
Nationwide and Puerto Rico
Recall date
December 24, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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