FDAFDA · Food and drugs·Recall number D-0801-2020
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.
Published January 29, 2020 · Recall initiated: January 14, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- METHYLPREDNISOLONE SODIUM SUCCINATE
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Distributor
- Nationwide in the USA
- Lot
- Lot #: 1901113.1, Exp JUL 2021
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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