FDA recall D-059-2013

Dr. Reddy's Laboratories, Inc. · Class II · drug

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

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.

Key facts

Status: Terminated
Initiation date: 2012-09-27
Report date: 2012-11-28
Termination date: 2013-07-10
Voluntary/Mandated: Voluntary: Firm initiated
Location: Bridgewater, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-059-2013