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 2.5% / CYCLO 1%/ TROP 1%/ KETO 0.5%) OPHTH SOLN, 5 ML per dropper bottle, RXQ Compounding, 340 West S…

Recall number

D-1715-2019

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 2.5% / CYCLO 1%/ TROP 1%/ KETO 0.5%) OPHTH SOLN, 5 ML per dropper bottle, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC 70731-0205-05