Recalls / Class III
Class IIID-855-2013
Product
BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic, LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217, NDC 67767-142-30, UPC 3 67767-142-30 6.
- Affected lot / code info
- Lot #: CG2D18A, Exp 06/14
Why it was recalled
Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification limits.
Recalling firm
- Firm
- Actavis Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy, N/A, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 15,132 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2013-07-31
- FDA classified
- 2013-08-08
- Posted by FDA
- 2013-08-14
- Terminated
- 2014-05-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-855-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.