Drug recall D-0468-2017

Class III Terminated reported Feb 15, 2017

Product

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

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.

Lots and codes

C500202

Recall details

Recalling firm
Dr. Reddy's Laboratories, Inc., Princeton, NJ
Quantity
5,904 bottles
Distribution
US Nationwide
Type
Voluntary: Firm initiated
Recall initiated
October 13, 2016
Terminated
July 24, 2017

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