FDA recall D-1446-2020

Product

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

Reason for recall

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

Distribution

United States including Puerto Rico

Key facts

Status

Terminated

Initiation date

2020-07-20

Report date

2020-08-12

Termination date

2022-12-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

New York, NY, United States

Primary source

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