FDA recall D-0933-2023

Product

Norepinephrine 16 mg per 250 mL (64 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per carton, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-602-01.

Reason for recall

Lack of Assurance of Sterility

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2023-07-07

Report date

2023-07-26

Termination date

2024-07-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Plattsburgh, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0933-2023