drugs Class II Updated 2013-07-24

American Health Packaging recalls QUETIAPINE Fumarate Tablets 25mg 100 Tablets (10x10) Bliste

Recalled 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

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot 122600 Exp. 03/14
View official government recall

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