D-0038-2021 Class II Ongoing
FDA drug recall D-0038-2021 was initiated by Genesis Partnership Company SA on September 11, 2020 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 15,000 bottles.
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
- 15,000 bottles
Product Description
Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution, 240 mL (8 FL OZ.) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, NDC 74484-002-02, UPC 7401037205773.
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