FDA-Drug2020-08-12Class II

Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL) 2 mL Single-dose Fliptop Vials, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045 USA NDC 0409-9094-12

Pfizer Inc.
Hazard

Lack of Assurance of Sterility; potential loose metal overseal crimp defects.

Sold states
United States including Puerto Rico
Affected count
19,144 vials
Manufactured in
235 E 42nd St, New York, NY, United States
Products
Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL) 2 mL Single-dose Fliptop Vials, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045 USA NDC 0409-9094-12

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1446-2020

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