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Class III · Lower riskRecall completed

Methylprednisolone Sodium Succinate

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot #: 1901113.1, Exp JUL 2021
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byHikma Pharmaceuticals USA Inc.
Brand nameMETHYLPREDNISOLONE SODIUM SUCCINATE
Generic nameMETHYLPREDNISOLONE SODIUM SUCCINATE
Active ingredient(s)METHYLPREDNISOLONE SODIUM SUCCINATE
Distributed by / forHikma Pharmaceuticals USA Inc.
NDC0143-9850-01
Show the full FDA record
Full product labelmethylPREDNISolone 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.
Recalling firmHikma Pharmaceuticals USA Inc.
DistributionNationwide in the USA
Quantity4840 vials
Recall initiated2020-01-14
Report date2020-01-29
Recall completed2021-09-08
Recall numberD-0801-2020
ClassificationClass III
FDA statusTerminated
Origin on fileCherry Hill NJ United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.