QUETIAPINE Fumarate Tablets 25mg 100 Tablets (10x10) Blister card, Rx, Packaged and Distributed ...
FDA Recall #D-802-2013 — Class II — October 10, 2012
Product Description
QUETIAPINE Fumarate Tablets 25mg 100 Tablets (10x10) Blister card, Rx, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-530-01
Reason for Recall
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.
Recalling Firm
American Health Packaging — Columbus, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
19060 blister cards
Distribution
Nationwide
Code Information
Lot 122600 Exp. 03/14
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated