Class III
Terminated
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.
- Company
- Actavis Inc
- Recall Initiated
- July 31, 2013
- Posted
- August 14, 2013
- Recall Number
- D-855-2013
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 15,132 bottles
- Firm Location
- Parsippany, NJ, United States
Reason for Recall
Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification limits.
Distribution
Nationwide and Puerto Rico
Lot / Code Info
Lot #: CG2D18A, Exp 06/14
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