FDARecall 99533Medicines
What to do
The FDA record of this recall has no instruction for consumers. Compare the lot codes below with your product. If they match, do not use it, and follow the notice of the firm or ask the store where you bought it. Talk to your pharmacist or doctor before stopping a medicine.Note from Recalls Watch, not agency text.
Read the official notice on accessdata.fda.gov (opens in a new tab)
Hazard
Why it was recalled
Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
FDA classification: Class I. FDA’s highest class: a reasonable probability that using the product will cause serious health consequences or death. Status: Ongoing.
Is it yours? Products and codes
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
- Lot or code
- Lot #: 6402820, Exp. Date 12/2028
- FDA recall number
- D-0788-2026
- Quantity
- 625500 syringes
Distribution (FDA): Nationwide within the USA.
About this record
- Issued by
- U.S. Food and Drug Administration
- Firm
- Fresenius Kabi USA, LLC (other notices of this firm)
- Title
- Composed by Recalls Watch from fields of the record; FDA records have no title.