Pfizer Inc. recalls Levophed (norepinephrine bitartrate) injection, USP, 4 mg/4 mL (1mg/mL), 4mL Fill in 5 mL Single dose Fliptop Vial, Rx o
Recalled September 27, 2017 · FDA recall D-1168-2017 · Pfizer
Hazard
Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process. · FDA Class II
Units
98,050 vials
Sold at
United States Nationwide (including Puerto Rico) and Singapore
Description
Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
Product
Levophed (norepinephrine bitartrate) injection, USP, 4 mg/4 mL (1mg/mL), 4mL Fill in 5 mL Single dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3375-04
Manufacturer(s)
Pfizer Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →