Status
Terminated
Drug Enforcement D-855-2013
Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification limits.
Classification
Class III
Report Date
August 14, 2013
Termination Date
May 9, 2014
Product Information
- Product description
- 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.
- Product quantity
- 15,132 bottles
- Reason for recall
- Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification limits.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Puerto Rico
Location & Firm
- Recalling firm
- Actavis Inc
- Address
-
400 Interpace Pkwy, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-855-2013
- Event ID
- 65881
- Recall initiation date
- July 31, 2013
- Center classification date
- August 8, 2013
- Code info
- Lot #: CG2D18A, Exp 06/14
- More code info
- —