Recall: D-0856-2021

Class II - Potentially Harmful

Class IIClassification

2021-09-17Initiated

TerminatedStatus

Fresenius Kabi USA LLCFirm

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

Defective container: Cracked vials leading to lack of sterility assurance

Distribution

U.S.A. Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.