Recalls / Class II
Class IID-66251-001
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
- Affected lot / code info
- Lot #: 705791A, Exp 04/2015
Why it was recalled
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.
Recalling firm
- Firm
- Watson Laboratories Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 132 Business Center Dr, Corona, California 92880-1724
Distribution
- Quantity
- 10,615 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-09-13
- FDA classified
- 2013-10-03
- Posted by FDA
- 2013-10-09
- Terminated
- 2014-07-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-66251-001. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.