Drug 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.
D-0699-2017
Product summary
- Event
- Event 76819
- Status
- Terminated
- Classification
- Class III
- Quantity
- 60 bottles
- Official record key
drug-enforcement:D-0699-2017
Official wording
Reason: Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Code information: Lot #: JKP2751A, Exp 05/17; JKR5048A, Exp 04/18
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Potency or specification failure
out of specification