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-

FDA recall notice · announced August 14, 2013 · Actavis

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Reason for recall

Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification limits.

Notes

Distribution: Nationwide and Puerto Rico
Lot/code information: Lot #: CG2D18A, Exp 06/14
Quantity: 15,132 bottles
Status: Terminated
Products in this recall event:
- 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 Packag (D-855-2013)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.