Class II
Terminated
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
- Company
- Dr. Reddy'S Laboratories, Inc.
- Recall Initiated
- September 27, 2012
- Posted
- November 28, 2012
- Recall Number
- D-059-2013
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1512 bottles
- Firm Location
- Bridgewater, NJ, United States
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.
Distribution
Nationwide. No foreign consignees.
Lot / Code Info
Lot C203090 Exp.03/14
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