Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenous use, Rx only, Fre…
Fresenius Kabi USA, LLC · Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
- Status
- Ongoing
- City
- Lake Zurich
- State
- IL
- Country
- United States
- Classification
- Class I
- Product type
- Drugs
- Event ID
- 99533
- Recalling firm
- Fresenius Kabi USA, LLC
- Address 1
- 3 Corporate Dr
- Postal code
- 60047-8930
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution pattern
- Nationwide within the USA.
- Recall number
- D-0788-2026
- Product quantity
- 625500 syringes
- Reason for recall
- Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
- Recall initiation date
- 20260804
- Center classification date
- 20260824
- Report date
- 20260826
- Code info
- Lot #: 6402820, Exp. Date 12/2028
- Product description
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
- Harmonized identifiers (openFDA)
- Application number
- NDA204223
- Brand name
- MORPHINE SULFATE
- Generic name
- MORPHINE SULFATE
- Manufacturer name
- Fresenius Kabi, USA LLC
- Product NDC
- 76045-004, 76045-238, 76045-005, 76045-006, 76045-007, 76045-008
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- INTRAMUSCULAR, INTRAVENOUS
- Substance name
- MORPHINE SULFATE
- RxCUI
- 894912, 894914, 998212, 998213, 1442790, 2752697
- SPL ID
- e61f6eb4-cc71-47d3-b2f6-5e689c773779
- SPL set ID
- 1f53de80-efc8-4930-b3e3-fba0d026af05
- Package NDC
- 76045-238-01, 76045-238-10, 76045-004-01, 76045-004-11, 76045-005-01, 76045-005-11, 76045-006-01, 76045-006-11, 76045-007-01, 76045-007-11, 76045-008-01, 76045-008-11
- Is original packager
- true
- UNII
- X3P646A2J0