FDA-Drug2013-07-24Class II
QUETIAPINE Fumarate Tablets 25mg 100 Tablets (10x10) Blister card, Rx, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-530-01
American Health Packaging
Hazard
Failed Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.
Sold states
Nationwide
Affected count
19060 blister cards
Manufactured in
2550 John Glenn Ave, Suite A, Columbus, OH, United States
Products
QUETIAPINE Fumarate Tablets 25mg 100 Tablets (10x10) Blister card, Rx, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-530-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-802-2013Don't want to check this manually?
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