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.

FDA recall notice · announced February 5, 2014 · Watson Laboratories

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Reason for recall

Failed Tablet/Capsule Specifications; Product contains broken tablets.

Notes

Distribution: Nationally in: AZ, CA, CT, FL, NV, OH, OK, PA, SC, WI.
Lot/code information: Lot #: 697316A, Expiry: Mar 2015.
Quantity: 717 bottles
Status: Terminated
Products in this recall event:
- 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. (D-1053-2014)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.