Fresenius Kabi, an operating company of the Fresenius Group, is voluntarily recalling one lot of Morphine Sulfate Injection USP, Simplist 2 mg/1 mL due to a label mix-up.
The recall centres on a mislabeling error in which a Morphine Sulfate Injection USP, Simplist 2 mg/1 mL seal was paired with Dilaudid (HYDROmorphone HCl) Injection, USP Simplist 0.5 mg/0.5 mL syringes from lot 6402813.
The MicroVault labeled as Morphine 2 mg/1 mL may in fact contain a prefilled syringe of Dilaudid 0.5 mg/0.5 mL, creating a serious and potentially fatal risk of medication error.
Dilaudid, also known as hydromorphone, is a significantly more potent opioid than morphine, meaning a patient receiving the wrong drug could experience a dangerous and unintended overdose.
Fresenius Kabi has stated that use of the mislabeled product carries a reasonable probability of causing serious adverse health consequences, including life-threatening respiratory depression and death.
Patients considered most at risk include those who do not regularly use opioids, individuals with underlying respiratory disease, pediatric patients, and those already taking central nervous system depressants.
The affected lot number is 6402820, carrying an expiration date of December 2028, and the product was distributed nationwide to distributors and wholesalers across the United States.
As of the recall announcement, Fresenius Kabi confirmed no adverse event reports had been received in connection with the affected lot number.
Healthcare facilities in possession of the affected lot are being instructed to immediately discontinue distributing, dispensing, or administering the product and to return all units to Fresenius Kabi without delay.
Distributors are also being urged to notify any customers who have been shipped or may have been shipped the recalled product to ensure the widest possible containment of the affected stock.
Fresenius Kabi is actively arranging for the return of the recalled product and has set up a dedicated contact line for healthcare providers and consumers with questions about the recall.
Those seeking further information can contact Fresenius Kabi USA Quality Assurance at 866-716-2459, available Monday through Friday between 8am and 5pm Central Time.