Class III
Terminated
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.
- Company
- Hikma Pharmaceuticals Usa Inc.
- Recall Initiated
- January 14, 2020
- Posted
- January 29, 2020
- Recall Number
- D-0801-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 4840 vials
- Firm Location
- Cherry Hill, NJ, United States
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.
Distribution
Nationwide in the USA
Lot / Code Info
Lot #: 1901113.1, Exp JUL 2021
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