FDA recall D-0508-2019

US Compounding Inc · Class II · drug

Product

Ephedrine Sulfate, 50 mg/10 mL, 10 mL Single Use Syringe, Rx only, US Compounding Pharmacy 1270 Don's Lane Conway, AR 800-718-3588, Barcode: 62295308407

Reason for recall

Lack of assurance of sterility.

Distribution

U.S.A. Nationwide

Key facts

Status
Terminated
Initiation date
2019-01-29
Report date
2019-02-27
Termination date
2020-01-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Conway, AR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0508-2019