Drug 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.
D-1053-2014
Product summary
- Event
- Event 67348
- Status
- Terminated
- Classification
- Class II
- Quantity
- 717 bottles
- Official record key
drug-enforcement:D-1053-2014
Official wording
Reason: Failed Tablet/Capsule Specifications; Product contains broken tablets.
Code information: Lot #: 697316A, Expiry: Mar 2015.
Distribution pattern: Nationally in: AZ, CA, CT, FL, NV, OH, OK, PA, SC, WI.
Derived failure modes
-
Unknown
Failed Tablet/Capsule Specifications; Product contains broken tablets.