FDA recall D-1311-2020

Product

Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx Only, SCA Pharmaceuticals 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0650-46

Reason for recall

Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.

Distribution

Product was distributed to hospitals in PA and CA.

Key facts

Status

Terminated

Initiation date

2020-06-16

Report date

2020-06-24

Termination date

2021-03-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Windsor, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1311-2020