Dr. Reddy's Laboratories, Inc. recalls Dr. Reddy's Quetiapine Fumarate Tablets, 25mg, Rx Only, 500 tablets. Mfd By: Dr. Reddy's Laboratories Limited, Bachep
Recalled November 28, 2012 · FDA recall D-059-2013 · Dr. Reddy's Laboratories
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. · FDA Class II
Units
1512 bottles
Sold at
Nationwide. No foreign consignees.
Description
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.
Product
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
Manufacturer(s)
Dr. Reddy's Laboratories, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →