Why it was recalled
CGMP Deviations: Product manufactured using expired active ingredient, Benzalkonium chloride.
Product description
Maxim Instant Foam Hand Sanitizer (benzalkonium chloride 0.1%) packaged in a) 1 U.S. Gallon (3.78 Liters) drums UPC 7 61841 02502 6 and b) 55 U.S. Gallon drums (208 Liters) UPC 0 07 61841 02504 0, Midlab 140 Private Brand Way, Athens, TN 37303
Lot numbers, UPCs & expiration codes
Lot #: a) 03292022-1, 05092022-1, 02012022-1, 06172022-1, 12132021-1, 07272022-1, and b) 06252022-1
Where it was sold
Naionwide within the 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-1463-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 8, 2022
- FDA report date
- Aug 31, 2022
- Quantity
- 892 gallons and one 55-gallon drum
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Midlab Incorporated
Original FDA data
Every field from FDA enforcement report D-1463-2022, exactly as published.
Show all FDA fields
- City
- Athens
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 90756
- Address
- 140 Private Brand Way
- Code information
- Lot #: a) 03292022-1, 05092022-1, 02012022-1, 06172022-1, 12132021-1, 07272022-1, and b) 06252022-1
- Postal code
- 37303-1401
- Report date
- Aug 31, 2022
- Product type
- Drugs
- Recall number
- D-1463-2022
- Classification
- Class II
- Recalling firm
- Midlab Incorporated
- Product quantity
- 892 gallons and one 55-gallon drum
- Termination date
- Aug 15, 2023
- Reason for recall
- CGMP Deviations: Product manufactured using expired active ingredient, Benzalkonium chloride.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Maxim Instant Foam Hand Sanitizer (benzalkonium chloride 0.1%) packaged in a) 1 U.S. Gallon (3.78 Liters) drums UPC 7 61841 02502 6 and b) 55 U.S. Gallon drums (208 Liters) UPC 0 07 61841 02504 0, Midlab 140 Private Brand Way, Athens, TN 37303
- Distribution pattern
- Naionwide within the United States
- Recall initiation date
- Aug 8, 2022
- Initial firm notification
- Letter
- Center classification date
- Aug 25, 2022