Drug 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.
D-0039-2021
Product summary
- Event
- Event 86427
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5,040 bottles
- Official record key
drug-enforcement:D-0039-2021
Official wording
Reason: CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol levels.
Code information: Lot #: 37009, Exp. 02/10/2021
Distribution pattern: Nationwide in the U.S.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations