Why it was recalled
cGMP deviations: Product made at the same facility where product tested was sub-potent.
Product description
Pristine gel Hand Sanitizer Gel Antibacterial Gel Moisturizing, 8.45 Fl. Oz. (250 mL) Bottle, Distributed by: Universal Distributors LLC, 6197 S. Rural Rd.,Tempe AZ, 85283, Made in Mexico by: Gaza Proveedora De Servicios De Hospedaje y Alimentos S.A. de C.V., UPC 8 64972 00049 5, NDC 76540-100-02
Lot numbers, UPCs & expiration codes
All Lots
Where it was sold
TX
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-0229-2021
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Dec 1, 2020
- FDA report date
- Jan 20, 2021
- Quantity
- 26,000 liters
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION
Original FDA data
Every field from FDA enforcement report D-0229-2021, exactly as published.
Show all FDA fields
- City
- Tonala
- Status
- Ongoing
- Country
- Mexico
- Event ID
- 86898
- Address
- Castilla 1473a Coloniajardines De
- Address (line 2)
- Tonala
- Code information
- All Lots
- Report date
- Jan 20, 2021
- Product type
- Drugs
- Recall number
- D-0229-2021
- Classification
- Class II
- Recalling firm
- GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION
- Product quantity
- 26,000 liters
- Reason for recall
- cGMP deviations: Product made at the same facility where product tested was sub-potent.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Pristine gel Hand Sanitizer Gel Antibacterial Gel Moisturizing, 8.45 Fl. Oz. (250 mL) Bottle, Distributed by: Universal Distributors LLC, 6197 S. Rural Rd.,Tempe AZ, 85283, Made in Mexico by: Gaza Proveedora De Servicios De Hospedaje y Alimentos S.A. de C.V., UPC 8 64972 00049 5, NDC 76540-100-02
- Distribution pattern
- TX
- Recall initiation date
- Dec 1, 2020
- Initial firm notification
- Letter
- Center classification date
- Jan 14, 2021