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 I

FDA recall notice · announced February 22, 2023 · Hto Nevada

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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%).

Reason for recall

cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.

Notes

Distribution: Nationwide in the USA and Canada.
Lot/code information: Lot #: 795CP-0003, Exp 07/2024.
Quantity: 1,571 bottles
Status: Terminated
Products in this recall event:
- New & Improved Blue Gel Anesthetic, to reduce pain and swelling during pain sensitive procedures, 1 oz bottle, distributed by Dermal Source, Portland, OR, www.dermalsource.com 1-888-568-3223. NDC Code (D-0270-2023)
- 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 (D-0271-2023)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.