FDA Drug recall D-0230-2021
Zapien Productos Hand Sanitizer Gel Antibacterial, 33.8 FL. OZ (1000 mL), Made by GAZA S.A. DE C.V. Castilla St. #1473-A ZIP 45410 Tonala,…
- FDA Drug
- Class II
- ongoing
- Published 2021-01-20
On 2021-01-20 the FDA classified a Class II recall of Zapien Productos Hand Sanitizer Gel Antibacterial, 33.8 FL. OZ (1000 mL), Made by GAZA S.A. DE C.V. Castilla St. #1473-A ZIP 45410 Tonala,… 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-0230-2021 |
| 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
Zapien Productos Hand Sanitizer Gel Antibacterial, 33.8 FL. OZ (1000 mL), Made by GAZA S.A. DE C.V. Castilla St. #1473-A ZIP 45410 Tonala, Jalisco, Mexico, UPC: 7 501700 623504, NDC numbers: 76938-001-01, 76938-001-02, 76938-001-03.
Reason
cGMP deviations: Product made at the same facility where product tested was sub-potent.
Identifiers
| upc | 7501700623504 |
|---|---|
| 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-0230-2021%22
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