FDA Drug recall D-0229-2021
Pristine gel Hand Sanitizer Gel Antibacterial Gel Moisturizing, 8.45 Fl. Oz. (250 mL) Bottle, Distributed by: Universal Distributors LLC, 6…
- FDA Drug
- Class II
- ongoing
- Published 2021-01-20
On 2021-01-20 the FDA classified a Class II recall of Pristine gel Hand Sanitizer Gel Antibacterial Gel Moisturizing, 8.45 Fl. Oz. (250 mL) Bottle, Distributed by: Universal Distributors LLC, 6… by Gaza Proveedora De Servicios De Hospedaje Y Alimentacion, citing cGMP deviations: Product made at the same facility where product tested was sub-potent.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0229-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-12-01 |
| Published | 2021-01-20 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Gaza Proveedora De Servicios De Hospedaje Y Alimentacion |
| Distribution | TX |
Product
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
cGMP deviations: Product made at the same facility where product tested was sub-potent.
Identifiers
| upc | 864972000495 |
|---|---|
| code_info | All Lots |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0229-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.