FDAClass INovember 28, 2012

Hydrocodone Bitartrate and Acetaminophen Tablets USP recall: Superpotent

Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, 500-count Tablets per bottle, Rx only, Manufactured By: Watson Laboratories, Inc.…

Why was Hydrocodone Bitartrate and Acetaminophen Tablets USP recalled?

Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets.

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 #: 519406A, 521759A, Exp 04/14

Product
Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, 500-count Tablets per bottle, Rx only, Manufactured By: Watson Laboratories, Inc.…
Recalling firm
Watson Laboratories Inc
Quantity
4,874 bottles
Distribution
Nationwide
Recall date
November 28, 2012
Classification
Class I
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls