Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0220-2019·Announced 2018-11-14

S.C. Johnson Recalls Deb Stoko Refresh AntiBac Foam Due to CGMP Deviations

S.C. Johnson Professional is recalling 869 cases of Deb Stoko Refresh AntiBac Foam because the product was released to market before microbiological testing was completed.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a CGMP deviation (release prior to testing) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

S.C. Johnson Professional is recalling 869 cases of deb stoko, Refresh AntiBac FOAM (benzalkonium chloride), 0.13%, 1 L (33.8 fl. oz.) cartridges. The product is packaged in cases of 8 cartridges and is identified by NDC 11084-010-27 and Lot 9131. The recall is limited to North Carolina.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the product was released to the market prior to the completion of required microbiological testing. This procedural error means the safety and quality of the product were not fully verified before distribution.

Consumers and businesses who possess this product should stop using it and contact S.C. Johnson Professional for instructions on how to return the product or obtain a refund. No illnesses or injuries have been reported in connection with this recall.

The recalled product

Product: 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.
Manufacturer: S.C. Johnson Professional
Category: Drug — Antiseptic
Hazard: cgmp-deviation
untested-product
Affected units: 869

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

Lot 9131

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 2 recalled by S.C. Johnson Professional under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · S.C. Johnson Professional

See all →

Moderate
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FDA (Drugs) · 2018-11-14

Same hazard · cgmp deviation