D-0702-2017 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 17, 2017
- Initiation Date
- March 22, 2017
- Termination Date
- July 11, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,784 bottles
Product Description
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.
Reason for Recall
Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Distribution Pattern
Nationwide in the USA and Puerto Rico
Code Information
Lot #: a) JKR5759A, Exp 04/18; b) JKP0943A, Exp 04/17, JKR5520A, Exp 04/18; c) JKP0988A, Exp 04/17