Recalls / Class III
Class IIID-1061-2013
Product
Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5 mg/650 mg Tablets, 500 Count Bottle, Manufactured by: Watson Laboratories, Inc, Cocona, CA 92880, NDC 0591-2611-05.
- Affected lot / code info
- Lot 706224A and 706225A, Exp. 04/15.
Why it was recalled
Defective Container: Defective bottles may not have tamper evident seals properly seated, and therefore it may be difficult to determine if the product had been opened or tampered with.
Recalling firm
- Firm
- Watson Laboratories Inc
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 132 Business Center Dr, N/A, Corona, California 92880-1724
Distribution
- Quantity
- 875 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-08-30
- FDA classified
- 2013-09-17
- Posted by FDA
- 2013-09-25
- Terminated
- 2014-07-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1061-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.