TURBO DROPS OPHTH SOLN recalled over sterility concerns

Recall date

June 19, 2019

Source

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

Official notice title

RXQ Compounding LLC recalls TURBO DROPS (PHEN 0.625%/CYCLO 0.25%/TROP 0.25%/KETO 0.125%) OPHTH SOLN, 0.4 ML per Syringe, RXQ Compounding, 340 West…

Recall number

D-1713-2019

FDA classification

Class II

Brand / firm

RXQ Compounding LLC

Sold / distributed

Nationwide USA

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

TURBO DROPS (PHEN 0.625%/CYCLO 0.25%/TROP 0.25%/KETO 0.125%) OPHTH SOLN, 0.4 ML per Syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC 70731-0192-81