Recalls / Class II
Class IID-1053-2014
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.
- Affected lot / code info
- Lot #: 697316A, Expiry: Mar 2015.
Why it was recalled
Failed Tablet/Capsule Specifications; Product contains broken tablets.
Recalling firm
- Firm
- Watson Laboratories Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 132 Business Center Dr, Corona, California 92880-1724
Distribution
- Quantity
- 717 bottles
- Distribution pattern
- Nationally in: AZ, CA, CT, FL, NV, OH, OK, PA, SC, WI.
Timeline
- Recall initiated
- 2014-01-15
- FDA classified
- 2014-01-30
- Posted by FDA
- 2014-02-05
- Terminated
- 2014-07-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1053-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.