FDAClass IIFebruary 5, 2014

Hydrocodone Bitartrate and Acetaminophen Tablets USP recall

Hydrocodone Bitartrate and Acetaminophen Tablets USP, CIII, 10 mg/ 660 mg, 100 count bottles, Rx only. Manufactured by Watson Laboratories, Inc., Corona, CA 92880. Distributed by: Watson Pharma, Inc. NDC: 00591-0517-01.

Why was Hydrocodone Bitartrate and Acetaminophen Tablets USP recalled?

Failed Tablet/Capsule Specifications; Product contains broken 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 #: 697316A, Expiry: Mar 2015.

Product
Hydrocodone Bitartrate and Acetaminophen Tablets USP, CIII, 10 mg/ 660 mg, 100 count bottles, Rx only. Manufactured by Watson Laboratories, Inc., Corona, CA 92880. Distributed by: Watson Pharma, Inc. NDC: 00591-0517-01.
Recalling firm
Watson Laboratories Inc
Quantity
717 bottles
Distribution
Nationally in: AZ, CA, CT, FL, NV, OH, OK, PA, SC, WI.
Recall date
February 5, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls