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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Dr. Reddy's Quetiapine Fumarate Tablets, 25mg, Rx Only, 500 tablets. Mfd By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325, India NDC 55111-249-05
Failed USP 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 USP 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.
