FDAClass IIMay 28, 2014

Promethazine Hydrochloride Tablets recall

PROMETHAZINE HYDROCHLORIDE Tablets, USP, 25 mg, 100 Tablet Bottles, Rx Only. Manufactured by: Cadila Healthcared Ltd., India. Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534. NDC: 68382-041-01

Why was Promethazine Hydrochloride Tablets recalled?

Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles.

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 #: MN9081, Expiry: 09/2015

Product
PROMETHAZINE HYDROCHLORIDE Tablets, USP, 25 mg, 100 Tablet Bottles, Rx Only. Manufactured by: Cadila Healthcared Ltd., India. Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534. NDC: 68382-041-01
Recalling firm
Zydus Pharmaceuticals USA Inc
Quantity
10,200 bottles
Distribution
Nationwide
Recall date
May 28, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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