FDA recall D-1075-2017

Cantrell Drug Company · Class II · drug

Product

Sodium Bicarbonate 8.4% Injection Solution 50 mL, 50 mEq (1mEq/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222

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-1075-2017