Recalls / Class II
Class IID-0220-2019
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.
- Brand name
- Refresh Antibac Foam
- Generic name
- Benzalkonium Chloride
- Active ingredient
- Benzalkonium Chloride
- Route
- Topical
- NDC
- 11084-010
- FDA application
- 505G(a)(3)
- Affected lot / code info
- Lot 9131
Why it was recalled
CGMP Deviations: Product was released to market prior to microbiological testing.
Recalling firm
- Firm
- S.C. Johnson Professional
- Manufacturer
- SC Johnson Professional USA Inc.
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 2815 Coliseum Centre Dr Ste 600, Charlotte, North Carolina 28217-0144
Distribution
- Quantity
- 869 cases
- Distribution pattern
- NC
Timeline
- Recall initiated
- 2018-10-26
- FDA classified
- 2018-11-06
- Posted by FDA
- 2018-11-14
- Terminated
- 2020-09-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0220-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.