FDA-Drug2017-09-27Class II
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
Pfizer Inc.
Hazard
Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
Sold states
United States Nationwide (including Puerto Rico) and Singapore
Affected count
98,050 vials
Manufactured in
235 E 42nd St, N/A, New York, NY, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1168-2017Don't want to check this manually?
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