TOPIC: One Lot of Morphine Sulfate Injection, USP in a Simplist Prefilled Syringe by Fresenius Kabi
AUDIENCE: Patient, Health Care Professional, Pharmacy, Pulmonology, Cardiology, Neurology, Pediatric
ISSUE: Fresenius Kabi is recalling one lot of Morphine Sulfate Injection USP, Simplist 2 mg / 1 mL due to a label mix-up. The MicroVault labeled as Morphine 2 mg / 1 mL, may contain a Prefilled Syringe of Dilaudid 0.5 mg / 0.5 mL. This recall is being conducted to the user level.
Use of a MicroVault labeled as Morphine Sulfate Injection 2 mg / mL containing a prefilled syringe of Dilaudid (hydromorphone HCl) 0.5 mg / 0.5 mL has a reasonable probability of causing serious adverse health consequences, including life-threatening respiratory depression and death. Patients at greatest risk include individuals who do not use opioids on a regular basis, those with underlying respiratory disease, pediatric patients, and those who are also taking central nervous system (CNS) depressants.
Product was distributed nationwide to distributors and wholesalers.
To date, no adverse event reports have been received for this lot number.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: Morphine Sulfate Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
RECOMMENDATIONS:
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Patients should contact their physician or health care provider if they have experienced any problems that may be related to receiving this drug product.
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Consumers with questions regarding this recall can contact Fresenius Kabi USA Quality Assurance at 1-866-716-2459 or send an e-mail to either productcomplaint.USA@fresenius-kabi.com or adverse.events.USA@fresenius-kabi.com.
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If health care facilities have any of the affected lots, they are to immediately discontinue distributing, dispensing, or using the lots and return all units to Fresenius Kabi.
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Distributors are instructed to immediately notify their customers that have been shipped or may have been shipped, the product involved in this recall.
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