D-0699-2017 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
- 60 bottles
Product Description
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.
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 #: JKP2751A, Exp 05/17; JKR5048A, Exp 04/18