Calcium Chloride Preservative Free recalled over sterility concerns

Recall date

March 7, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

TMC Acquisition LLC dba Tailor Made Compounding recalls Calcium Chloride Preservative Free, 100mg/mL, a) 5 mL-vial, b) 30 ml-vial, Room Temperature, Tailor Made Compounding

Recall number

D-1198-2022

FDA classification

Class II

Brand / firm

TMC Acquisition LLC dba Tailor Made Compounding

Sold / distributed

Nationwide USA and Puerto Rico

Why it was recalled

Lack of Assurance of Sterility

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Calcium Chloride Preservative Free, 100mg/mL, a) 5 mL-vial, b) 30 ml-vial, Room Temperature, Tailor Made Compounding