Potassium Hydroxide 10% recalled over mold contamination

Recall date

July 1, 2021

Source

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

Official notice title

Gibson Bioscience recalls Potassium Hydroxide 10% (KOH 10%), Cat. No. 300145 Potassium Hydroxide 10% (KOH 10%) is intended for use in the demonst…

Recall number

Z-2450-2021

FDA classification

Class II

Brand / firm

Gibson Bioscience

Sold / distributed

US Domestic distribution to NY, KY, ME, NC, NY, CO, CA, and SC.

Why it was recalled

A lot of KOH 10% was made with Hydrogen Peroxide 3% instead of KOH 10%.

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

What was recalled

Potassium Hydroxide 10% (KOH 10%), Cat. No. 300145 Potassium Hydroxide 10% (KOH 10%) is intended for use in the demonstration of yeast and fungal elements in wet clinical preparations. Potassium Hydroxide digests the proteinaceous material in the specimen, leaving the fungal cell wall intact for direct microscopic observation.