D-855-2013 Class III Terminated
FDA drug recall D-855-2013 was initiated by Actavis Inc on Jul 31, 2013 and is designated Class III. Reason for recall: Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification limits. The recall status is terminated (terminated May 9, 2014). Affected quantity: 15,132 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Aug 14, 2013
- Initiation Date
- Jul 31, 2013
- Termination Date
- May 9, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15,132 bottles
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.
Reason for recall
Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification limits.
Distribution pattern
Nationwide and Puerto Rico
Code information
Lot #: CG2D18A, Exp 06/14
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-855-2013
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026