FDAClass IIIDecember 10, 2014

BENZONATATE Capsules recall

BENZONATATE Capsules, USP, 200 mg, 100 Capsule Bottles, Rx only. Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA, Inc. NDC: 68382-248-01

Why was BENZONATATE Capsules recalled?

Presence of Foreign Capsules/Tablets: Benzonatate 100 mg co-mingled with benzonatate 200 mg 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 #: MM8555, Expiry: 09/14; Lot #: MM6604, Expiry: 09/14; Lot #: MM8551, Expiry: 09/14; Lot #: MM8552, Expiry: 09/14; Lot #: MM8553, Expiry: 09/14; Lot #: MM8554, Expiry: 09/14.

Product
BENZONATATE Capsules, USP, 200 mg, 100 Capsule Bottles, Rx only. Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA, Inc. NDC: 68382-248-01
Recalling firm
Zydus Pharmaceuticals USA Inc
Quantity
63,648 Bottles
Distribution
US Nationwide including Puerto Rico
Recall date
December 10, 2014
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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