Drug product
PROBLEND Hand Sanitizer, Refreshing Gel Hand Sanitizer, Ethanol 70% v/v Antiseptic, mountain spring scent, 1250 mL cases, Seatex LLC, 445 TX Hwy 36 Rosenberg, YX 77471
D-0360-2024
Product summary
- Firm
- Seatex LLC
- Event
- Event 93986
- Status
- Terminated
- Classification
- Class II
- Quantity
- 480 cases
- Official record key
drug-enforcement:D-0360-2024
Official wording
Reason: CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Code information: Lot #: 266029, Exp. 03/27/2024.
Distribution pattern: Nationwide in the US and Puerto Rico
Derived failure modes
-
Manufacturing or process control
CGMP Deviations: deficiencies