Fresenius Kabi Recalls Morphine Syringes Due to Labeling Error
Fresenius Kabi is recalling 625,500 Morphine Sulfate syringes because some were mislabeled and contained Dilaudid instead.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death.
Plain-English summary
Fresenius Kabi USA, LLC is recalling 625,500 units of Morphine Sulfate Injection, USP, 2 mg/mL, 1 mL single-dose Simplist prefilled syringes. The recall is due to a labeling error where MicroVault units were labeled as Morphine 2 mg/1 mL but actually contained a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
The affected product is identified by Lot # 6402820 with an expiration date of 12/2028. The product was distributed nationwide within the USA. The NDC numbers for the unit of use and unit of sale are 76045-004-01 and 76045-004-11, respectively.
Healthcare providers and consumers should check their inventory for this specific lot number and stop using the product if it matches the description. They should contact Fresenius Kabi USA, LLC for further instructions on how to return or dispose of the affected syringes.
The recalled product
- Product
- MORPHINE SULFATE (MORPHINE SULFATE)
- Brand
- MORPHINE SULFATE
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug — Prescription Injection
- Hazard
- Affected units
- 625,500
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 #: 6402820
- Exp. Date 12/2028
Distribution
Distributed nationwide across the United States.
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