FDA recall D-0948-2018

Product

HEPARIN 1,000 Units in NS 250mL. (Heparin Sodium, USP 1,000 Units, 0.9% Sodium Chloride, USP 250 mL) Volume: 251 mL. Single dose bag. For: Adventist Medical Center Hanford. By: Avella of Huston, 9265 Kirby Dr., Houston TX, 77054. NDC 42852-747-25

Reason for recall

Lack of Assurance of Sterility: Potential leakage of bags.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2018-06-12

Report date

2018-07-25

Termination date

2020-01-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Phoenix, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0948-2018