Drug product
methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only, Mfd by: HIKMA FARMACEUTICA (PORTUGAL), SA; Dist by: WEST-WARD, Eatontown, NJ 07724, NDC 0143-9850-01.
D-0801-2020
Product summary
- Event
- Event 84676
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4840 vials
- Official record key
drug-enforcement:D-0801-2020
Official wording
Reason: Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to reconstitute product with 16 mL rather than the correct volume of 8 mL of Bacteriostatic Water for Injection with Benzyl Alcohol.
Code information: Lot #: 1901113.1, Exp JUL 2021
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect