FDA recall D-0301-2022

SterRx, LLC · Class II · drug

Product

Morphine Sulfate in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY, 12903, NDC 70324-427-02.

Reason for recall

Lack of Assurance of Sterility

Distribution

U.S.A. Nationwide

Key facts

Status
Terminated
Initiation date
2021-11-12
Report date
2022-01-05
Termination date
2023-12-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Plattsburgh, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0301-2022