FDA-Drug2021-10-06Class II
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
Fresenius Kabi USA LLC
Hazard
Defective container: Cracked vials leading to lack of sterility assurance
Sold states
U.S.A. Nationwide
Affected count
963000 vials
Manufactured in
2020 N Ruby St, N/A, Melrose Park, IL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0856-2021Don't want to check this manually?
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