openFDA Drug Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
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QUETIAPINE Fumarate Tablets 25mg 100 Tablets (10x10) Blister card, Rx, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-530-01
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.
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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.
