Drug product
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.
D-0702-2017
Product summary
- Event
- Event 76819
- Status
- Terminated
- Classification
- Class III
- Quantity
- 14,784 bottles
- Official record key
drug-enforcement:D-0702-2017
Official wording
Reason: Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Code information: Lot #: a) JKR5759A, Exp 04/18; b) JKP0943A, Exp 04/17, JKR5520A, Exp 04/18; c) JKP0988A, Exp 04/17
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Potency or specification failure
out of specification