FDA recall D-0932-2023

SterRx, LLC · Class II · drug

Product

Norepinephrine 8 mg per 250 mL (32 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-577-01.

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-0932-2023