Drug Enforcement D-0271-2023

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

Status

Terminated

Classification

Class II

Report Date

February 22, 2023

Termination Date

November 17, 2023

Product Information

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%).
Product quantity
1,571 bottles
Reason for recall
cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA and Canada.

Location & Firm

Recalling firm
HTO Nevada, Inc.
Address
6400 Rosewood St, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0271-2023
Event ID
91694
Recall initiation date
February 9, 2023
Center classification date
February 15, 2023
Code info
Lot #: 795CP-0003, Exp 07/2024.
More code info
—