FDA Recall D-0230-2021

GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION · Tonala, N/A

Class II Ongoing 1990 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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.

Lot / code: All Lots

Quantity: 43875 liters

Reason for recall

cGMP deviations: Product made at the same facility where product tested was sub-potent.

Recall record

Recall number: D-0230-2021
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: TX
Recall initiated: 2020-12-01
Classified by FDA Center: 2021-01-14
FDA published: 2021-01-20
Recalling firm: GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION
Firm location: Tonala, N/A, Mexico

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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