Recalls / Class III
Class IIID-892-2013
Product
buPROPion Hydrochloride Extended Release Tablets, USP 100 mg, 100 count carton, 10 blister cards of 10 individually blistered and labeled tablets, Rx only, Actavis South Atlantic LLC, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-470-01
- Affected lot / code info
- The following codes are affects by the recall: Lot #114500, Exipration Date 08/2013, repackaging date 12/04/2011.
Why it was recalled
Failed Stability Specifications; out of specification results at the 9 month stability time point for color, dissolution and related compounds.
Recalling firm
- Firm
- American Health Packaging
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave, Suite A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 389 cartons
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-02-04
- FDA classified
- 2013-08-15
- Posted by FDA
- 2013-08-21
- Terminated
- 2013-08-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-892-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.