FDA-Drug2013-08-21Class III
buPROPion Hydrochloride Extended Release Tablets, USP 100 mg, 100 count carton, 10 blister cards of 10 individually blistered and labeled tablets, Rx only, Actavis South Atlantic LLC, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-470-01
American Health Packaging
Hazard
Failed Stability Specifications; out of specification results at the 9 month stability time point for color, dissolution and related compounds.
Sold states
Nationwide
Affected count
389 cartons
Manufactured in
2550 John Glenn Ave, Suite A, Columbus, OH, United States
Products
buPROPion Hydrochloride Extended Release Tablets, USP 100 mg, 100 count carton, 10 blister cards of 10 individually blistered and labeled tablets, Rx only, Actavis South Atlantic LLC, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-470-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-892-2013Don't want to check this manually?
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