Drug & medication recalls Moderate risk

Deb stoko recalled over manufacturing violations

Recall date
October 26, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
S.C. Johnson Professional recalls deb stoko, Refresh AntiBac FOAM (benzalkonium chloride), 0.13%, 1 L (33.8 fl. oz.) cartridge packaged in 8 cartridges p…
Recall number
D-0220-2019
FDA classification
Class II
Brand / firm
S.C. Johnson Professional
Sold / distributed
NC

Why it was recalled

CGMP Deviations: Product was released to market prior to microbiological testing.

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

What was recalled

deb stoko, Refresh AntiBac FOAM (benzalkonium chloride), 0.13%, 1 L (33.8 fl. oz.) cartridge packaged in 8 cartridges per case, Made in the USA, Deb USA, Inc., Charlotte, NC 28217, NDC 11084-010-27.

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