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.
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.
Lot numbers, UPCs & expiration codes
Lot #: 37009, Exp. 02/10/2021
Where it was sold
Nationwide in the U.S.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0038-2021
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Sep 11, 2020
- FDA report date
- Oct 28, 2020
- Quantity
- 15,000 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Genesis Partnership Company SA
Original FDA data
Every field from FDA enforcement report D-0038-2021, exactly as published.
Show all FDA fields
- City
- Villa Nueva
- Status
- Ongoing
- Country
- Guatemala
- Event ID
- 86427
- Address
- Km 19.5 Carretera Al Pacifico, Bodega 28
- Code information
- Lot #: 37009, Exp. 02/10/2021
- Report date
- Oct 28, 2020
- Product type
- Drugs
- Recall number
- D-0038-2021
- Classification
- Class II
- Recalling firm
- Genesis Partnership Company SA
- Product quantity
- 15,000 bottles
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the U.S.
- Recall initiation date
- Sep 11, 2020
- Initial firm notification
- Letter
- Center classification date
- Oct 19, 2020