Opioid Analgesic Recalled

Fresenius Kabi USA is recalling four lots of morphine sulfate injection because of cracked vials and a subsequent lack of sterility assurance, according to the October 6, 2021, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects morphine sulfate injection, 1-mL single-dose vials packaged in 25-vial boxes (NDC 63323-452-01), from lots 6023731 (Exp. 3/23), 6023732 (Exp. 3/23), 6024172 (Exp. 6/23), and 6024260 (Exp. 6/23). The vials were distributed throughout the United States. 

Fresenius Kabi voluntarily initiated the recall September 17, 2021. On September 27, 2021, the FDA designated the recall Class II, signaling use of the drug could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists. 

Morphine sulfate injection is a prescription treatment for severe pain.