HTO Nevada, Inc. recalls Maximum Zone2 Topical Analgesic, 1oz bottle, for use during a pain sensitive procedure, distributed by: DERMAL SOURCE, P
Recalled February 22, 2023 · FDA recall D-0271-2023 · HTO Nevada
Hazard
cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API. · FDA Class II
Units
1,571 bottles
Sold at
Nationwide in the USA and Canada.
Description
cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
Product
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%).
Manufacturer(s)
HTO Nevada, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →