Recalls / Class III

Class IIID-0701-2017

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.

Affected lot / code info

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

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

38,316 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-0701-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.