Drug recall D-0856-2021
Product
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
Reason for recall
Defective container: Cracked vials leading to lack of sterility assurance
Lots and codes
Lot # 6023731, 6023732, Exp 03/2023; 6024172, 6024260, Exp 06/2023
Recall details
- Recalling firm
- Fresenius Kabi USA LLC, Melrose Park, IL
- Quantity
- 963000 vials
- Distribution
- U.S.A. Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- September 17, 2021
- Terminated
- June 20, 2023
Related products
- Morphine Sulfate – drug information
- NDC 63323-455 Morphine Sulfate · Morphine Sulfate 5 mg/mL · Fresenius Kabi USA, LLC
- NDC 63323-458 Morphine Sulfate · Morphine Sulfate 8 mg/mL · Fresenius Kabi USA, LLC
- NDC 63323-452 Morphine Sulfate · Morphine Sulfate 2 mg/mL · Fresenius Kabi USA, LLC
- NDC 63323-454 Morphine Sulfate · Morphine Sulfate 4 mg/mL · Fresenius Kabi USA, LLC
- NDC 63323-451 Morphine Sulfate · Morphine Sulfate 10 mg/mL · Fresenius Kabi USA, LLC