Why it was recalled
Defective container: Cracked vials leading to lack of sterility assurance
Product description
Morphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-452-01. 25 vials per tray packaged 18 trays per shipper
Lot numbers, UPCs & expiration codes
Lot # 6023731, 6023732, Exp 03/2023; 6024172, 6024260, Exp 06/2023
Where it was sold
U.S.A. Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0856-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 17, 2021
- FDA report date
- Oct 6, 2021
- Quantity
- 963000 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fresenius Kabi USA LLC
Original FDA data
Every field from FDA enforcement report D-0856-2021, exactly as published.
Show all FDA fields
- City
- Melrose Park
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 88698
- Address
- 2020 N Ruby St
- Code information
- Lot # 6023731, 6023732, Exp 03/2023; 6024172, 6024260, Exp 06/2023
- Postal code
- 60160-1112
- Report date
- Oct 6, 2021
- Product type
- Drugs
- Recall number
- D-0856-2021
- Classification
- Class II
- Recalling firm
- Fresenius Kabi USA LLC
- Product quantity
- 963000 vials
- Termination date
- Jun 20, 2023
- Reason for recall
- Defective container: Cracked vials leading to lack of sterility assurance
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Morphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-452-01. 25 vials per tray packaged 18 trays per shipper
- Distribution pattern
- U.S.A. Nationwide
- Recall initiation date
- Sep 17, 2021
- Initial firm notification
- Letter
- Center classification date
- Sep 27, 2021