Drug recall D-0801-2020
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.
Reason for recall
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.
Lots and codes
Lot #: 1901113.1, Exp JUL 2021
Recall details
- Recalling firm
- Hikma Pharmaceuticals USA Inc., Cherry Hill, NJ
- Quantity
- 4840 vials
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- January 14, 2020
- Terminated
- September 8, 2021
Related products
- Methylprednisolone Sodium Succinate – drug information
- NDC 0143-9851 Methylprednisolone Sodium Succinate · Methylprednisolone Sodium Succinate 1 g/1 · Hikma Pharmaceuticals USA Inc.
- NDC 0143-9850 Methylprednisolone Sodium Succinate · Methylprednisolone Sodium Succinate 500 mg/1 · Hikma Pharmaceuticals USA Inc.