FDA-Drug2012-11-28Class II
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
Dr. Reddy's Laboratories, Inc.
Hazard
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.
Sold states
Nationwide. No foreign consignees.
Affected count
1512 bottles
Manufactured in
200 Somerset Corporate Blvd Fl 7th, N/A, Bridgewater, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-059-2013Don't want to check this manually?
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