FDA recall D-1551-2020

Product

Heparin Sodium 5,000 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use (10 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0650-44, Bar Code 70004065044.

Reason for recall

Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.

Distribution

Nationwide within the U.S.

Key facts

Status

Terminated

Initiation date

2020-07-29

Report date

2020-09-02

Termination date

2021-05-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Windsor, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1551-2020