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

Code information: Lot #: a) JKP1354A, Exp 03/17, JKP2746A, Exp 06/17, JKR5751A, Exp 04/18; b) JKP1355A, Exp 03/17, JKP2738A, JKP3145A, Exp 06/17, JKR5476A, Exp 04/18; c) JKP1353A, Exp 03/17, JKP3146A, JKP2746B, Exp 06/17

Distribution pattern: Nationwide in the USA and Puerto Rico