Recalls / Class II
Class IID-0356-2024
Product
PROBLEND Antibacterial Foaming Silk All-In-One Foaming Hand Sanitizer & Cleanser, Benzalkonium Chloride 0.13% Antibacterial, a) 1250 mL cases, b) 1 G cases, mountain spring scent, Seatex LLC, 445 TX Hwy 36 Rosenberg, TX 77471.
- Affected lot / code info
- Lot #s: a) 263647, Exp. 06/09/2024; 271382, Exp. 01/18/2025; b) 261675, Exp. 04/09/2024; 263647, Exp. 06/09/2024; 272766, Exp.02/15/2025.
Why it was recalled
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Recalling firm
- Firm
- Seatex LLC
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 445 Highway 36 N, Rosenberg, Texas 77471-8756
Distribution
- Quantity
- 1,450 cases
- Distribution pattern
- Nationwide in the US and Puerto Rico
Timeline
- Recall initiated
- 2024-02-19
- FDA classified
- 2024-02-29
- Posted by FDA
- 2024-03-06
- Terminated
- 2025-08-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0356-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.