Fresenius Kabi USA, LLC: Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenous use, Rx only, Fres
Read the official notice at FDA (press release) →
The text below is copied from the official FDA (press release) record. If anything differs, the official notice is correct.
- Company / brand
- Fresenius Kabi USA, LLC
- Product
- Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenous use, Rx only, Fresenius Kabi, Lake Zurich, IL. Unit of Use NDC Number 76045-004-01; Unit of Sale NDC Number 76045-004-11
- Reason / hazard
- Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
- Classification
- Class I
- Status
- Ongoing
- Distribution / sold at
- Nationwide within the USA.
- Recall initiated
- 2026-08-04
- Product type
- Drugs,
- Code info
- Lot #: 6402820, Exp. Date 12/2028
- Product quantity
- 625500 syringes
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Lake Zurich
- State
- IL
- Country
- United States
- Event id
- 99533
- Enforcement url
- https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99533
- Enforcement id
- fda-drug-D-0788-2026
- Announced product
- Morphine Sulfate Injection USP, Simplist® 2 mg/1 mL
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