Maxim Instant Foam Hand Sanitizer (benzalkonium chloride 0.1%) packaged in a) 1 U.S. Gallon (3.78...
FDA Recall #D-1463-2022 — Class II — August 8, 2022
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
Reason for Recall
CGMP Deviations: Product manufactured using expired active ingredient, Benzalkonium chloride.
Recalling Firm
Midlab Incorporated — Athens, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
892 gallons and one 55-gallon drum
Distribution
Naionwide within the United States
Code Information
Lot #: a) 03292022-1, 05092022-1, 02012022-1, 06172022-1, 12132021-1, 07272022-1, and b) 06252022-1
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated