HTO Nevada Inc., doing business as Kirkman, is initiating a Class II recall for its MAXIMUM, ZONE 1, 4% Lidocaine Cream (NDC 80069-014) distributed nationwide. The reason for the recall is that the stability data does not support the product's stated expiry date, raising concerns about product efficacy and safety over time.

This recall requires immediate action from distributors and potentially consumers who may possess the affected product. While classified as Class II, which suggests less severe health risks than Class I recalls, the product's integrity is compromised. Companies involved in the distribution chain must ensure the product is removed from inventory and accounted for according to recall procedures. The FDA will monitor the effectiveness of this recall to ensure the product is no longer available to consumers.