Drug product
Oxaliplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptford, NJ 08066-1742 (856) 384-7001, NDC 49821-0075-XX
D-1882-2019
Product summary
- Event
- Event 83457
- Status
- Terminated
- Classification
- Class II
- Quantity
- 316703.32
- Official record key
drug-enforcement:D-1882-2019
Official wording
Reason: cGMP Deviations: Potential glass contamination
Code information: Lot #: B0126-170701; B0126-170802; Exp. Sep 2022; B0126-180401, Exp. May 2023; B0126-180702, B0126-180803, Exp. Oct 2023
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
cGMP Deviations