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
Panagel Hand Sanitizer, 70% Alcohol,16 Fl. Oz. (472 mL) bottle, Made in Guatemala, Distributed by Central Med Distribution, 6100 Hollywood Blvd, Hollywood FL 33024, NDC 78384-001-04, UPC 378384000016.
Lot numbers, UPCs & expiration codes
Lot #: 072120, Exp. 01/21/2022
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-0037-2021
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Sep 11, 2020
- FDA report date
- Oct 28, 2020
- Quantity
- 33,480 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Genesis Partnership Company SA
Original FDA data
Every field from FDA enforcement report D-0037-2021, 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 #: 072120, Exp. 01/21/2022
- Report date
- Oct 28, 2020
- Product type
- Drugs
- Recall number
- D-0037-2021
- Classification
- Class II
- Recalling firm
- Genesis Partnership Company SA
- Product quantity
- 33,480 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
- Panagel Hand Sanitizer, 70% Alcohol,16 Fl. Oz. (472 mL) bottle, Made in Guatemala, Distributed by Central Med Distribution, 6100 Hollywood Blvd, Hollywood FL 33024, NDC 78384-001-04, UPC 378384000016.
- Distribution pattern
- Nationwide in the U.S.
- Recall initiation date
- Sep 11, 2020
- Initial firm notification
- Letter
- Center classification date
- Oct 19, 2020