FDA recall D-0835-2020

Product

Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL), 2 mL Single-dose Vial, Each Tray contains 25 Vials, Intravenous or Intramuscular Use, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045, NDC 00409-9094-12 (vial), 00409-9094-22 (tray).

Reason for recall

Defective Container: confirmed customer reports for vials with loose metal overseal crimp defects, which may result in lack of assurance of sterility.

Distribution

Nationwide in the U.S. and Puerto Rico

Key facts

Status

Terminated

Initiation date

2020-02-03

Report date

2020-02-19

Termination date

2022-09-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0835-2020