Why it was recalled
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Product description
PROBLEND Antibacterial Foaming Silk All-In-One Foaming Hand Sanitizer & Cleanser, Benzalkonium Chloride 0.13% Antibacterial, a) 1250 mL cases, b) 1 G cases, mountain spring scent, Seatex LLC, 445 TX Hwy 36 Rosenberg, TX 77471.
Lot numbers, UPCs & expiration codes
Lot #s: a) 263647, Exp. 06/09/2024; 271382, Exp. 01/18/2025; b) 261675, Exp. 04/09/2024; 263647, Exp. 06/09/2024; 272766, Exp.02/15/2025.
Where it was sold
Nationwide in the US and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0356-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 19, 2024
- FDA report date
- Mar 6, 2024
- Quantity
- 1,450 cases
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Seatex LLC
Original FDA data
Every field from FDA enforcement report D-0356-2024, exactly as published.
Show all FDA fields
- City
- Rosenberg
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 93986
- Address
- 445 Highway 36 N
- Code information
- Lot #s: a) 263647, Exp. 06/09/2024; 271382, Exp. 01/18/2025; b) 261675, Exp. 04/09/2024; 263647, Exp. 06/09/2024; 272766, Exp.02/15/2025.
- Postal code
- 77471-8756
- Report date
- Mar 6, 2024
- Product type
- Drugs
- Recall number
- D-0356-2024
- Classification
- Class II
- Recalling firm
- Seatex LLC
- Product quantity
- 1,450 cases
- Termination date
- Aug 15, 2025
- Reason for recall
- CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- PROBLEND Antibacterial Foaming Silk All-In-One Foaming Hand Sanitizer & Cleanser, Benzalkonium Chloride 0.13% Antibacterial, a) 1250 mL cases, b) 1 G cases, mountain spring scent, Seatex LLC, 445 TX Hwy 36 Rosenberg, TX 77471.
- Distribution pattern
- Nationwide in the US and Puerto Rico
- Recall initiation date
- Feb 19, 2024
- Initial firm notification
- Center classification date
- Feb 29, 2024