Hikma Pharmaceuticals USA Inc. is recalling 4,840 vials of methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg. The vial labels contain incorrect instructions, directing healthcare providers to mix the powder with 16 mL of liquid instead of the correct 8 mL volume. This error could lead to a patient receiving an incorrect or diluted dose of the medication. This prescription drug is used to treat various conditions including inflammation and severe allergic reactions. Consumers should consult their doctor or pharmacist immediately if they believe they have been treated with this specific lot.
If the medication is prepared according to the incorrect label instructions, the drug will be over-diluted by double the intended amount of liquid. This could result in patients receiving a lower dose than prescribed, potentially failing to control serious inflammatory or allergic conditions.
Contact healthcare provider and return product for refund.
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Sources: FDA iRES · Raw API Response
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