Methylcobalamin 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 Methylcobalamin Preservative Free, 10mg/mL, 1mL-vial, Room Temperature, Tailor Made Compounding

Recall number

D-1217-2022

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

Methylcobalamin Preservative Free, 10mg/mL, 1mL-vial, Room Temperature, Tailor Made Compounding