Hikma Recalls Methylprednisolone Sodium Succinate Injection Due to Labeling Error
Hikma Pharmaceuticals is recalling 4,840 vials of Methylprednisolone Sodium Succinate Injection because the label incorrectly instructs healthcare professionals to reconstitute the product with 16 mL instead of 8 mL.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a low risk of adverse health consequences. The hazard is a minor labeling error regarding reconstitution volume, which fits the criteria for a moderate severity score due to the potential for improper preparation without reported harm.
Plain-English summary
Hikma Pharmaceuticals USA Inc. is recalling 4,840 vials of Methylprednisolone Sodium Succinate for Injection, USP, 500 mg/vial. The product is distributed nationwide in the USA and is identified by Lot # 1901113.1 with an expiration date of JUL 2021. The drug is manufactured by HIKMA FARMACEUTICA (PORTUGAL), SA and distributed by WEST-WARD in Eatontown, NJ.
The recall was initiated due to a labeling error. The vial label incorrectly instructs healthcare professionals to reconstitute the product with 16 mL of Bacteriostatic Water for Injection with Benzyl Alcohol, rather than the correct volume of 8 mL. This error could lead to improper preparation of the medication.
Healthcare professionals and patients should check their inventory for this specific lot number and expiration date. If the product is found, it should be removed from use and returned to the distributor or manufacturer according to standard recall procedures. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- METHYLPREDNISOLONE SODIUM SUCCINATE (METHYLPREDNISOLONE SODIUM SUCCINATE)
- Brand
- METHYLPREDNISOLONE SODIUM SUCCINATE
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Category
- Drug — Prescription Injection
- Hazard
- Affected units
- 4,840
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 1901113.1
- Exp JUL 2021
Distribution
Distributed nationwide across the United States.
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