FDAFDA · Food and drugs·Recall number D-059-2013
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
Published November 28, 2012 · Recall initiated: September 27, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Distributor
- Nationwide. No foreign consignees.
- Lot
- Lot C203090 Exp.03/14
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States