FDA recall D-0947-2018

Product

HEPARIN 12,500 Units in 5% Dextrose. (Heparin Sodium, USP 12,500 Units, 5% Dextrose Inj., USP 250 mL) Volume: 252.5 mL. Single dose bag. Avella Specialty Pharmacy, 24416 N 19th Avenue Phoenix, AZ 85085. NDC 42852-745-25

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-0947-2018