FDA-Drug2014-12-17Class II

Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, 50 mL Single-dose Flip top Vial (C-II), Rx only, 25 units per box/50 units per case, Hospira Inc., Lake Forest, IL --- NDC 0409-9094-61

Hospira Inc.
Hazard

Lack of Assurance of Sterility; improperly crimped fliptop vials

Sold states
Nationwide
Affected count
62,650 vials
Manufactured in
375 N Field Dr, N/A, Lake Forest, IL, United States
Products
Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, 50 mL Single-dose Flip top Vial (C-II), Rx only, 25 units per box/50 units per case, Hospira Inc., Lake Forest, IL --- NDC 0409-9094-61

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0294-2015

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