Why it was recalled
CGMP Deviations: Product was released to market prior to microbiological testing.
Product description
Alcohol Free Foaming Hand Sanitizer (benzalkonium chloride), 0.13%, 1 L (33.8 fl. oz.) cartridge packaged in 8 cartridges per case, Safe-T-Fresh Inc., USA, 2530 Xenium Lane North, Minneapolis, MN 55441.
Lot numbers, UPCs & expiration codes
Lot 9085
Where it was sold
NC
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-0221-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 26, 2018
- FDA report date
- Nov 14, 2018
- Quantity
- 258 cases
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- S.C. Johnson Professional
Original FDA data
Every field from FDA enforcement report D-0221-2019, exactly as published.
Show all FDA fields
- City
- Charlotte
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 81453
- Address
- 2815 Coliseum Centre Dr Ste 600
- Code information
- Lot 9085
- Postal code
- 28217-0144
- Report date
- Nov 14, 2018
- Product type
- Drugs
- Recall number
- D-0221-2019
- Classification
- Class II
- Recalling firm
- S.C. Johnson Professional
- Product quantity
- 258 cases
- Termination date
- Sep 8, 2020
- Reason for recall
- CGMP Deviations: Product was released to market prior to microbiological testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Alcohol Free Foaming Hand Sanitizer (benzalkonium chloride), 0.13%, 1 L (33.8 fl. oz.) cartridge packaged in 8 cartridges per case, Safe-T-Fresh Inc., USA, 2530 Xenium Lane North, Minneapolis, MN 55441.
- Distribution pattern
- NC
- Recall initiation date
- Oct 26, 2018
- Initial firm notification
- Telephone
- Center classification date
- Nov 6, 2018