FDA recall D-0271-2023

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.

Distribution

Nationwide in the USA and Canada.

Key facts

Status

Terminated

Initiation date

2023-02-09

Report date

2023-02-22

Termination date

2023-11-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Oswego, OR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0271-2023