Drug 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.
D-0356-2024
Product summary
- Firm
- Seatex LLC
- Event
- Event 93986
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,450 cases
- Official record key
drug-enforcement:D-0356-2024
Official wording
Reason: CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Code information: 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.
Distribution pattern: Nationwide in the US and Puerto Rico
Derived failure modes
-
Manufacturing or process control
CGMP Deviations: deficiencies