American Health Packaging recalls QUETIAPINE Fumarate Tablets 25mg 100 Tablets (10x10) Blister card, Rx, Packaged and Distributed by: American Health Pac
Recalled July 24, 2013 · FDA recall D-802-2013 · 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. · FDA Class II
Units
19060 blister cards
Sold at
Nationwide
Description
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.
Product
QUETIAPINE Fumarate Tablets 25mg 100 Tablets (10x10) Blister card, Rx, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-530-01
Manufacturer(s)
American Health Packaging
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →