FDA 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

Distribution

U.S.A. Nationwide

Key facts

Status

Terminated

Initiation date

2021-09-17

Report date

2021-10-06

Termination date

2023-06-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Melrose Park, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0856-2021