D-0039-2021 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- October 28, 2020
- Initiation Date
- September 11, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,040 bottles
Product Description
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.
Reason for Recall
CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol levels.
Distribution Pattern
Nationwide in the U.S.
Code Information
Lot #: 37009, Exp. 02/10/2021