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Recall Observatory FDA recall evidence

Drug 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.

D-1587-2020

August 06, 2020

Class I

Product summary

Firm
Incredible Products, SA de CV
Event
Event 86199
Status
Terminated
Classification
Class I
Quantity
N/A
Official record key
drug-enforcement:D-1587-2020

Official wording

Reason: Chemical Contamination: Product contains methanol as an active ingredient and is sub-potent for ethanol.

Code information: Lot #: 001, Exp. 04/2023

Distribution pattern: CA and GA

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Chemical Contamination