Class I recall: Fresenius Kabi USA, LLC: Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled s

Fresenius Kabi USA has issued a Class I recall for Morphine Sulfate Injection, USP, 2 mg/mL, 1 mL single-dose Simplist prefilled syringes (Unit of Use NDC 76045-004-01; Unit of Sale NDC 76045-004-11), intended for intramuscular or intravenous use. According to the recall notice, a labeling mixup occurred in which a MicroVault labeled as containing Morphine 2 mg/1 mL instead contains a prefilled syringe of Dilaudid 0.5 mg/0.5 mL. The recall is classified as Class I, the FDA's designation for situations where use of the affected product may cause serious injury or death.

Most relevant for: patients receiving morphine sulfate injections from affected batches of Fresenius Kabi's Simplist prefilled syringes who are at risk of receiving the incorrect medication (hydromorphone) due to labeling mixup

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