Product Safety Recalls

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Recall D-0360-2024

Description: 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

Recall D-0360-2024 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0360-2024
Event ID93986
DistributionNationwide in the US and Puerto Rico
Quantity480 cases
Recall ReasonCGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Drug ClassificationClass II
Drug Code Info20240306
Recall Initiation Date20240219
Report Date20240306
Classification Date20240229
Address445 Highway 36 N
Rosenberg, TX 77471-8756
United States
Recalling FirmSeatex LLC
Initial Notification E-Mail
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