D-0229-2021 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- January 20, 2021
- Initiation Date
- December 1, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26,000 liters
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
Reason for Recall
cGMP deviations: Product made at the same facility where product tested was sub-potent.
Distribution Pattern
TX
Code Information
All Lots