FDA-Drug2020-01-29Class III
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.
Hikma Pharmaceuticals USA Inc.
Hazard
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.
Sold states
Nationwide in the USA
Affected count
4840 vials
Manufactured in
2 Esterbrook Ln, Cherry Hill, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0801-2020Don't want to check this manually?
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