FDA-Drug2013-04-24Class 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.
Actavis South Atlantic LLC
Hazard
Failed USP Dissolution Test Requirements: Out-of-specification dissolution results at the 8 hour stability testing point.
Sold states
Nationwide
Affected count
555,672 bottles
Manufactured in
13800 Nw 2nd St Ste 190, N/A, Sunrise, FL, 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-248-2013Don't want to check this manually?
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