November 02, 2018
Pfizer Inc. is recalling more than 71,000 vials of meropenem injection, 1 gram/vial (NDC 0409-3506-11), 25 vials per carton (NDC 0409-3506-01), manufactured for Hospira Inc., according to the October 31, 2018, US Food and Drug Administration (FDA) Enforcement Report.
The recall was voluntarily initiated September 20, 2018, due to a lack of sterility assurance.
The recall affects vials from lot 609G047 (Exp. 10/18). The affected vials were distributed throughout the United States and in Puerto Rico.
The FDA designated the recall Class II October 24, 2018. The classification suggests use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.
Meropenem is a prescription injection used to treat skin and abdominal infections caused by bacteria and meningitis.
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