Recalls / Class II
Class IID-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
- Brand name
- Morphine Sulfate
- Generic name
- Morphine Sulfate
- Active ingredient
- Morphine Sulfate
- Route
- Intramuscular, Intravenous
- NDCs
- 63323-451, 63323-452, 63323-454, 63323-455, 63323-458
- FDA application
- NDA204223
- Affected lot / code info
- Lot # 6023731, 6023732, Exp 03/2023; 6024172, 6024260, Exp 06/2023
Why it was recalled
Defective container: Cracked vials leading to lack of sterility assurance
Recalling firm
- Firm
- Fresenius Kabi USA LLC
- Manufacturer
- Fresenius Kabi USA, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2020 N Ruby St, N/A, Melrose Park, Illinois 60160-1112
Distribution
- Quantity
- 963000 vials
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2021-09-17
- FDA classified
- 2021-09-27
- Posted by FDA
- 2021-10-06
- Terminated
- 2023-06-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0856-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.