FDA recall D-1061-2017

Product

Ephedrine Sulfate in 0.9% Sodium Chloride 10 mL, 50 mg/10 mL (5 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222, NDC 52533-019-12

Reason for recall

Lack of Sterility Assurance.

Distribution

Nationwide within the US

Key facts

Status

Terminated

Initiation date

2017-07-14

Report date

2017-08-16

Termination date

2020-09-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Little Rock, AR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1061-2017