Sun Pharmaceutical Industries, Inc. recalls Olanzapine Tablets, 20 mg, packaged in a) 30-count bottles (NDC 62756-556-83), b) 100-count bottles (NDC 62756-556-88),
Recalled May 17, 2017 · FDA recall D-0702-2017 · Sun Pharmaceutical Industries
Hazard
Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities). · FDA Class III
Units
14,784 bottles
Sold at
Nationwide in the USA and Puerto Rico
Description
Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Product
Olanzapine Tablets, 20 mg, packaged in a) 30-count bottles (NDC 62756-556-83), b) 100-count bottles (NDC 62756-556-88), and c) 1000-count bottles (NDC 62756-556-18), 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.
Manufacturer(s)
Sun Pharmaceutical Industries, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →