Recalls / Class II
Class IID-0039-2021
Product
Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution, 1 gallon (3785 mL) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, NDC 74484-002-04, UPC 7401037203427.
- Affected lot / code info
- Lot #: 37009, Exp. 02/10/2021
Why it was recalled
CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol levels.
Recalling firm
- Firm
- Genesis Partnership Company SA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Km 19.5 Carretera Al Pacifico, Bodega 28, N/A, Villa Nueva, N/A N/A, Guatemala
Distribution
- Quantity
- 5,040 bottles
- Distribution pattern
- Nationwide in the U.S.
Timeline
- Recall initiated
- 2020-09-11
- FDA classified
- 2020-10-19
- Posted by FDA
- 2020-10-28
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0039-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.