Sun Pharmaceutical Industries, Inc. recalls Olanzapine Tablets, 2.5 mg, 1000-count bottles, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury,

Recalled May 17, 2017 · FDA recall D-0699-2017 · Sun Pharmaceutical Industries

Hazard

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

Units

60 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, 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.

Manufacturer(s)

Sun Pharmaceutical Industries, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →