August 2020 FDA Recall Drug by Incredible Products, Sa De Cv
D-1587-2020 - Chemical Contamination

This Class I drug recall was voluntarily initiated by Incredible Products, Sa De Cv on August 6, 2020 for the product Drug. The FDA reported the reason for recall as chemical contamination. The product was distributed in CA and GA and the recall is currently terminated.

Recall Number: D-1587-2020

Reason for Recall
Chemical Contamination: Product contains methanol as an active ingredient and is sub-potent for ethanol.
Initiated
08-06-2020
Reported
09-30-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86199
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Incredible Products, SA de CV
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CA and GA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-26-2024
Product Description About Product Description
Full technical description of the product.
Incredible Products Gelbac T Antibacterial Hand Gel (ethyl alcohol 80%), Kills 99.9% bacteria and germs, a) 4.2 Oz./125 mL bottle, NDC: 71761-000-00, UPC: 7502278002555, Distributed by Pacific Coast Global Inc. Chula Vista, CA 91911, Made in Mexico b) 33.8 Oz./1 L, UPC: 7502278002586, Made in Mexico By Incredible Products S.A. de C.V. alle Castellanos y Tapia 921, Oblatos, 44350 Guadalajara, Jal, MX.

Batch or Lot Expiration Information

Lot# : 001, Exp. 04/2023