Drug product
Olanzapine tablets, USP, 2.5 mg, packaged in a 30-count bottle, Rx only, Mfd: By: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-163-30
D-0468-2017
Product summary
- Event
- Event 75442
- Status
- Terminated
- Classification
- Class III
- Quantity
- 5,904 bottles
- Official record key
drug-enforcement:D-0468-2017
Official wording
Reason: Failed impurities/degradation specifications: due to out-of-specification result for the Related Substance Compound C (Impurity 6 - N-Oxide at the 18 month stability station.
Code information: C500202
Distribution pattern: US Nationwide
Derived failure modes
-
Potency or specification failure
out-of-specification