FDA Recall D-1587-2020
Incredible Products, SA de CV · Guadalajara, N/A
Class I — life-threatening Terminated 1420 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Reason for recall
Chemical Contamination: Product contains methanol as an active ingredient and is sub-potent for ethanol.
Recall record
- Recall number
D-1587-2020- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- CA and GA
- Recall initiated
- 2020-08-06
- Classified by FDA Center
- 2020-09-18
- FDA published
- 2020-09-30
- Terminated
- 2024-06-26
- Recalling firm
- Incredible Products, SA de CV
- Firm location
- Guadalajara, N/A, Mexico