Recalls / Class II
Class IID-059-2013
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
- Affected lot / code info
- Lot C203090 Exp.03/14
Why it was recalled
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.
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 200 Somerset Corporate Blvd Fl 7th, N/A, Bridgewater, New Jersey 08807-2862
Distribution
- Quantity
- 1512 bottles
- Distribution pattern
- Nationwide. No foreign consignees.
Timeline
- Recall initiated
- 2012-09-27
- FDA classified
- 2012-11-20
- Posted by FDA
- 2012-11-28
- Terminated
- 2013-07-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-059-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.