FDAClass IIDecember 31, 2014

Benzonatate Capsules recall

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

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 #: MP2625, MP2626, MP2627 Exp 2/16; MP4875, MP4876, MP4877, MP4878 Exp 4/16; MP6482, MP6483, MP6484, MP6493, MP6494 Exp 6/16

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
Recalling firm
Zydus Pharmaceuticals USA Inc
Quantity
19,536 units
Distribution
Nationwide
Recall date
December 31, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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