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Recall Observatory FDA recall evidence

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

February 19, 2024

Class II

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

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations: deficiencies