FDAFDA · Food and drugs·Recall number D-0271-2023
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%).
Published February 22, 2023 · Recall initiated: February 9, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- HTO Nevada, Inc.
- Distributor
- Nationwide in the USA and Canada.
- Lot
- Lot #: 795CP-0003, Exp 07/2024.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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