← FDA ENFORCEMENT
D-0360-2024Class II

Seatex LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Seatex LLC
Product type
Drug
Status
Terminated
Report date
2024-03-06
Distribution
Nationwide in the US and Puerto Rico
Firm state
TX
Product quantity
480 cases
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
Reason for recall

CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.

Product 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

Code / lot info

Lot #: 266029, Exp. 03/27/2024.

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →