drugs Class II Updated 2012-11-28

Dr. Reddy's Laboratories, Inc. recalls Dr. Reddy's Quetiapine Fumarate Tablets, 25mg, Rx Only, 500

Recalled 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

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot C203090 Exp.03/14
View official government recall

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