Recalls / Class III

Class IIID-0700-2017

Product

Olanzapine Tablets, 7.5 mg, packaged in a) 30-count bottles (NDC 62756-553-83), b) 100-count bottles (NDC 62756-553-88), and c) 1000-count bottles (NDC 62756-553-18), 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.

Affected lot / code info

Lot #: a) JKP3150B, Exp 06/17, JKR5749A, Exp 06/18; b) JKP2757A, Exp 05/17, JKP3149A, JKP3150A, Exp 06/17, JKR5049A, Exp 04/18; c) JKP2758B, Exp 05/17

Why it was recalled

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

Recalling firm

Firm

Sun Pharmaceutical Industries, Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

270 Prospect Plains Rd, N/A, Cranbury, New Jersey 08512-3605

Distribution

Quantity

6,138 bottles

Distribution pattern

Nationwide in the USA and Puerto Rico

Timeline

Recall initiated

2017-03-22

FDA classified

2017-05-10

Posted by FDA

2017-05-17

Terminated

2018-07-11

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0700-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.