Olanzapine Tablets, 2.5 mg, 1000-count bottles, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-551-18.

Recall Number: D-0699-2017

Firm: Sun Pharmaceutical Industries, Inc.

Classification: Class III

Status: Terminated

Report Date: 20170517

Initiation Date: 20170322

Termination Date: 20180711

Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).

Olanzapine Tablets, 2.5 mg, 1000-count bottles, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-551-18.