Why it was recalled
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Product description
Avant Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per plastic carton, Manufactured for B4 Brands, Lisbon, Iowa 52253
Lot numbers, UPCs & expiration codes
Product Number 46076 Lot 722896-exp 07/22, 722996-exp 07/22
Where it was sold
Florida, Illinois, Iowa, New Jersey
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-1356-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 15, 2022
- FDA report date
- Aug 24, 2022
- Quantity
- 9,176 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aire-Master of America Inc
Original FDA data
Every field from FDA enforcement report D-1356-2022, exactly as published.
Show all FDA fields
- City
- Nixa
- State
- MO
- Status
- Terminated
- Country
- United States
- Event ID
- 90644
- Address
- 1821 N State Highway Cc
- Code information
- Product Number 46076 Lot 722896-exp 07/22, 722996-exp 07/22
- Postal code
- 65714-8015
- Report date
- Aug 24, 2022
- Product type
- Drugs
- Recall number
- D-1356-2022
- Classification
- Class II
- Recalling firm
- Aire-Master of America Inc
- Product quantity
- 9,176 cartons
- Termination date
- Feb 19, 2023
- Reason for recall
- CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Avant Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per plastic carton, Manufactured for B4 Brands, Lisbon, Iowa 52253
- Distribution pattern
- Florida, Illinois, Iowa, New Jersey
- Recall initiation date
- Jul 15, 2022
- Initial firm notification
- Letter
- Center classification date
- Aug 18, 2022