FDA-Drug2017-09-27Class II
HYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial, packaged in cartons of 25 vials, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3365-11 (carton) and 0409-3365-01(vial)
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
115,370 vials
Manufactured in
235 E 42nd St, N/A, New York, NY, United States
Products
HYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial, packaged in cartons of 25 vials, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3365-11 (carton) and 0409-3365-01(vial)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1167-2017Don't want to check this manually?
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