HTO Nevada Inc. dba Kirkman recalled 243 bottles of MAXIMUM ZONE 2, 4% lidocaine cream distributed nationwide by Dermal Source. The recall cites stability data that does not support an expiry date. Consumers and healthcare providers should stop using this product immediately and contact Kirkman for guidance.
Stability Data Does Not Support Expiry Date.
Consumers and healthcare providers should stop using this product immediately. Contact HTO Nevada Inc. dba Kirkman or your healthcare provider for guidance. Notification method: E-Mail
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NDC: 80069-015. Lot #: 795CP-0005. Expiry date: 06/30/2026. Size: 1 oz bottles. Quantity recalled: 243. Distribution: Nationwide within the United States. Distributor: Dermal Source, Portland, OR 97232.
The recall concerns a lidocaine cream with epinephrine where stability data does not support an expiry date. The lack of validated expiry dating raises questions about potency and sterility over time.
1. Stop using the product. 2. Contact HTO Nevada Inc. dba Kirkman or your healthcare provider for guidance. 3. Do not discard the product until advised. 4. Monitor recall updates at the FDA enforcement page. 5. For questions, follow the notice’s instructions and contact Kirkman.
Distributor: Dermal Source. Company: HTO Nevada Inc. dba Kirkman. Recall notice URL: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0387-2026. Notification method described as E-Mail.
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