Multi-event December 2020 FDA Recall Drug by Gaza Proveedora De Servicios De Hospedaje Y Alimentacion
This Multi-event Class II drug recall was voluntarily initiated by Gaza Proveedora De Servicios De Hospedaje Y Alimentacion on December 1, 2020 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in TX and the recall is currently ongoing.
Reported Recall Events
Recall Number: D-0229-2021
cGMP deviations: Product made at the same facility where product tested was sub-potent.
12-01-2020
01-20-2021
26,000 liters
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
TX
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# All Lots
Recall Number: D-0230-2021
cGMP deviations: Product made at the same facility where product tested was sub-potent.
12-01-2020
01-20-2021
43875 liters
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
TX
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# All Lots
