Recalls / Class III
Class IIID-0006-2023
Product
Antibacterial Foaming Wash with Hydria Moisturizing Formula, Cucumber-Melon Scent, 1250 mL (42 fl oz.), Manufactured for: Triple S, 800-323-2251, Made in USA, NDC 11429-1010-8
- Brand name
- Foamfresh Dye Free Antibacterial Hand Wash
- Generic name
- Chloroxylenol
- Active ingredient
- Chloroxylenol
- Route
- Topical
- NDC
- 11429-1010
- FDA application
- 505G(a)(3)
- Affected lot / code info
- Lot #: VDAF017, Exp 4/24; VDAF018, Exp 5/24
Why it was recalled
Labeling: Not Elsewhere Classified - Incorrect label-incorrect scent listed on label.
Recalling firm
- Firm
- Woodbine Products Co Inc
- Manufacturer
- Woodbine Products Company
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 915 W Smith Rd, N/A, Medina, Ohio 44256-2446
Distribution
- Quantity
- 595 cases (4 bottles per case)
- Distribution pattern
- NC
Timeline
- Recall initiated
- 2022-08-30
- FDA classified
- 2022-10-06
- Posted by FDA
- 2022-10-12
- Terminated
- 2023-09-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0006-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.