Why it was recalled
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Product description
Protect U Guard Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per carton, Manufactured for Protect U Guard, Tampa 33606.
Lot numbers, UPCs & expiration codes
Product Number 46112, Lots 722782 -exp 08/22
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-1358-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 15, 2022
- FDA report date
- Aug 24, 2022
- Quantity
- 960 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aire-Master of America Inc
Original FDA data
Every field from FDA enforcement report D-1358-2022, 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 46112, Lots 722782 -exp 08/22
- Postal code
- 65714-8015
- Report date
- Aug 24, 2022
- Product type
- Drugs
- Recall number
- D-1358-2022
- Classification
- Class II
- Recalling firm
- Aire-Master of America Inc
- Product quantity
- 960 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
- Protect U Guard Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per carton, Manufactured for Protect U Guard, Tampa 33606.
- Distribution pattern
- Florida, Illinois, Iowa, New Jersey
- Recall initiation date
- Jul 15, 2022
- Initial firm notification
- Letter
- Center classification date
- Aug 18, 2022