Recalls / Class II
Class IID-1463-2022
Product
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
- Affected lot / code info
- Lot #: a) 03292022-1, 05092022-1, 02012022-1, 06172022-1, 12132021-1, 07272022-1, and b) 06252022-1
Why it was recalled
CGMP Deviations: Product manufactured using expired active ingredient, Benzalkonium chloride.
Recalling firm
- Firm
- Midlab Incorporated
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 140 Private Brand Way, Athens, Tennessee 37303-1401
Distribution
- Quantity
- 892 gallons and one 55-gallon drum
- Distribution pattern
- Naionwide within the United States
Timeline
- Recall initiated
- 2022-08-08
- FDA classified
- 2022-08-25
- Posted by FDA
- 2022-08-31
- Terminated
- 2023-08-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1463-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.