HTO Nevada Inc. Issues Recall for Maximum Zone 1 Lidocaine Cream Due to Stability Concerns
HTO Nevada Inc. dba Kirkman is voluntarily recalling 178 bottles of Maximum Zone 1 4% Lidocaine Cream because stability data does not support the listed expiration date.
What Happened
HTO Nevada Inc. dba Kirkman has initiated a voluntary recall of Maximum Zone 1 4% Lidocaine Cream. The recall was issued because the firm’s stability data does not support the expiration date currently printed on the product packaging. This recall has been classified by the FDA as a Class II recall.
Which Products Are Affected
The recall involves 178 bottles of the following product:
- Product Name: MAXIMUM, ZONE 1, 4% Lidocaine Cream
- Size: 1/2 oz bottles
- NDC: 80069-014
- Lot Number: 807CP-0003
- Expiration Date: 07/31/2026
- Distributor: Dermal Source, Portland, OR
These products were distributed nationwide within the United States.
What You Should Do
Consumers who possess the affected lot of Maximum Zone 1 Lidocaine Cream should stop using the product immediately. For further information regarding returns or questions about the recall, consumers may contact HTO Nevada Inc. dba Kirkman, located in Lake Oswego, Oregon.
Why This Matters
Stability testing is essential to ensure that a medication maintains its labeled potency and safety throughout its entire shelf life. When stability data fails to support an expiration date, the product’s effectiveness and safety profile cannot be guaranteed through that date.
Source
Information provided by the FDA. Recall Number: D-0386-2026.
Source: FDA Official Notice