Home / Recalls / HTO Nevada, Inc. / D-0271-2023

D-0271-2023 Class II Terminated

Recalled by HTO Nevada, Inc. — Lake Oswego, OR

Recall Details

Product Type: Drugs
Report Date: February 22, 2023
Initiation Date: February 9, 2023
Termination Date: November 17, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1,571 bottles

Product Description

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 Pattern

Nationwide in the USA and Canada.

Code Information

Lot #: 795CP-0003, Exp 07/2024.