Olanzapine tablets, USP, 2.5 mg, packaged in a 30-count bottle, Rx only, Mfd: By: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-163-30
Recall Number: D-0468-2017
Firm: Dr. Reddy's Laboratories, Inc.
Classification: Class III
Status: Terminated
Report Date: 20170215
Initiation Date: 20161013
Termination Date: 20170724
Reason for Recall
Failed impurities/degradation specifications: due to out-of-specification result for the Related Substance Compound C (Impurity 6 - N-Oxide at the 18 month stability station.
Product Description
Olanzapine tablets, USP, 2.5 mg, packaged in a 30-count bottle, Rx only, Mfd: By: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-163-30