FDA recall D-1331-2022

Product

FentaNYL Citrate in 0.9% Sodium Chloride 1 mg per 100 mL (10 mcg per mL) IV bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-327-01.

Reason for recall

Lack of Assurance of Sterility

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2022-07-25

Report date

2022-08-17

Termination date

2023-06-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Plattsburgh, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1331-2022