Drug product
Decitabine for Injection, 50mg per vial, Rx only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323, NDC 69097-285-37
D-0698-2018
Product summary
- Event
- Event 79729
- Status
- Terminated
- Classification
- Class III
- Quantity
- 3222 vials
- Official record key
drug-enforcement:D-0698-2018
Official wording
Reason: Failed impurities/degradation specifications: Failure to water content and impurity
Code information: Lot #: GE70493, GE70502, GE70512, Exp 8/2019
Distribution pattern: U.S.A. nationwide
Derived failure modes
-
Potency or specification failure
Failed impurities/degradation specifications