Maximum Zone2 Topical Analgesic recalled over manufacturing violations
- Recall date
- February 9, 2023
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- HTO Nevada, Inc. recalls Maximum Zone2 Topical Analgesic, 1oz bottle, for use during a pain sensitive procedure, distributed by: DERMAL SOURCE,…
- Recall number
- D-0271-2023
- FDA classification
- Class II
- Brand / firm
- HTO Nevada, Inc.
- Sold / distributed
- Nationwide in the USA and Canada.
Why it was recalled
cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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%).
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