FDA-Drug2023-02-22Class II
Maximum Zone2 Topical Analgesic, 1oz bottle, for use during a pain sensitive procedure, distributed by: DERMAL SOURCE, Portland, OR, www.dermalsource.com, 1-866-568-3223, NDC code: 80069-012-01, Drug Facts- For use by licensed professionals only' Active Ingredients- Lidocaine HCL (5%), Epinephrine (0.01%).
HTO Nevada, Inc.
Hazard
cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
Sold states
Nationwide in the USA and Canada.
Affected count
1,571 bottles
Manufactured in
6400 Rosewood St, N/A, Lake Oswego, OR, United States
Products
Maximum Zone2 Topical Analgesic, 1oz bottle, for use during a pain sensitive procedure, distributed by: DERMAL SOURCE, Portland, OR, www.dermalsource.com, 1-866-568-3223, NDC code: 80069-012-01, Drug Facts- For use by licensed professionals only' Active Ingredients- Lidocaine HCL (5%), Epinephrine (0.01%).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0271-2023Don't want to check this manually?
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