Hikma Pharmaceuticals USA Inc. recalls methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only, Mfd by: HIKMA FARMACEUTICA (PORTUGAL), S…
- Recall date
- January 14, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0801-2020
- FDA classification
- Class III
- Brand / firm
- Hikma Pharmaceuticals USA Inc.
- Sold / distributed
- Nationwide in the USA
Why it was recalled
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.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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.
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