FDA recall D-0193-2017

Product

Heparin Sodium 5,000 USP Units Added to 0.9% Sodium Chloride 1,000 mL* Bag (5 USP units/mL), Single-Dose Bag.,Hospital/Office Use Only, Injection Solution For IV Use, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-097-24

Reason for recall

Lack of Assurance of Sterility - the firm is recalling select sterile drug products.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2016-11-18

Report date

2016-12-21

Termination date

2020-04-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Little Rock, AR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0193-2017