FDA recall record

Seatex 7 Eleven FOR GAS ISLAND USE ONLY, Hand Sanitizer, Ethanol 70% v/v Antiseptic recall — FDA D-0358-2024

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

Class IIclassification
D-0358-2024official record ID
Mar 6, 2024report date

Recall record at a glance

Official recordD-0358-2024
CategoryDrug Recalls
ClassificationClass II
FDA record statusTerminated
Recalling firmSeatex LLC
Report dateMar 6, 2024
Recall initiation dateFeb 19, 2024
Quantity3 cases
LocationRosenberg, TX, United States

Official product description

7 Eleven FOR GAS ISLAND USE ONLY, Hand Sanitizer, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 330 Gal. cases, Distributed by: Magnus, 16005 Gateway Drive, Suite 300, Frisco, TX 75033

Why the product was recalled

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

Distribution information

Nationwide in the US and Puerto Rico

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.

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