Status
Terminated
Drug Enforcement D-059-2013
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.
Classification
Class II
Report Date
November 28, 2012
Termination Date
July 10, 2013
Product Information
- Product description
- 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
- Product quantity
- 1512 bottles
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide. No foreign consignees.
Location & Firm
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Address
-
200 Somerset Corporate Blvd Fl 7th, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-059-2013
- Event ID
- 63524
- Recall initiation date
- September 27, 2012
- Center classification date
- November 20, 2012
- Code info
- Lot C203090 Exp.03/14
- More code info
- —