Why it was recalled
cGMP Deviations
Product description
Bersih Hand Sanitizer Gel, Net wt. 16.9 floz (500ml), Blue and Green cap) Distributed by RediBag USA 135 Fulton Ave New Hyde Park, NY 11040 UPC 8 16822 02666 7
Lot numbers, UPCs & expiration codes
All lots remaining within expiry.
Where it was sold
United States
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-1560-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 14, 2020
- FDA report date
- Sep 9, 2020
- Quantity
- 2,486,400 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Soluciones Cosmeticas, SA de CV
Original FDA data
Every field from FDA enforcement report D-1560-2020, exactly as published.
Show all FDA fields
- City
- Ciudad De Mexico
- Status
- Terminated
- Country
- Mexico
- Event ID
- 86042
- Address
- Avenida Ano De Juarez 110
- Address (line 2)
- Otro Granjas San Antonio, Iztapalapa
- Code information
- All lots remaining within expiry.
- Report date
- Sep 9, 2020
- Product type
- Drugs
- Recall number
- D-1560-2020
- Classification
- Class II
- Recalling firm
- Soluciones Cosmeticas, SA de CV
- Product quantity
- 2,486,400 bottles
- Termination date
- Feb 22, 2022
- Reason for recall
- cGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Bersih Hand Sanitizer Gel, Net wt. 16.9 floz (500ml), Blue and Green cap) Distributed by RediBag USA 135 Fulton Ave New Hyde Park, NY 11040 UPC 8 16822 02666 7
- Distribution pattern
- United States
- Recall initiation date
- Jul 14, 2020
- Initial firm notification
- Press Release
- Center classification date
- Sep 2, 2020