FDA-Drug2013-08-14Class III
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.
Actavis Inc
Hazard
Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification limits.
Sold states
Nationwide and Puerto Rico
Affected count
15,132 bottles
Manufactured in
400 Interpace Pkwy, N/A, Parsippany, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-855-2013Don't want to check this manually?
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