Product: Olanzapine Tablets, 10 mg, packaged in a) 30-count bottles (NDC 62756-554-83), b) 100-count bottles (NDC 62756-554-88), and c) 1000-count bottles (NDC 62756-554-18), 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.
Reason for recall: Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Recall initiated: 20170322
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated