FDA recall D-0318-2022

SterRx, LLC · Class II · drug

Product

MORPHINE SULFATE, in 0.9% Sodium Chloride Injection, 50 mg per 50 mL, (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-427-01.

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-0318-2022