Drug product
Oxycodone and Acetaminophen Tablets, USP 10 mg/650 mg, CII, 100 Count Bottles, Rx Only, Manufactured by: Watson Laboratories, Inc. Corona, CA 92880 USA, NDC 0591-0825-01
D-66251-001
Product summary
- Event
- Event 66251
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10,615 bottles
- Official record key
drug-enforcement:D-66251-001
Official wording
Reason: Presence of Foreign Tablets/Capsules: 20 tablets of Oxycodone/APAP 7.5/500 mg were found in a sealed 100 count bottle of Oxycodone and Acetaminophen Tablets, USP 10/650 mg lot# 705791A.
Code information: Lot #: 705791A, Exp 04/2015
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets