HTO Nevada, Inc.: Drug Recall
Recall #D-0271-2023 · 02/09/2023
Class II: Risk
Recall Details
- Recall Number
- D-0271-2023
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- HTO Nevada, Inc.
- Status
- Terminated
- Date Initiated
- 02/09/2023
- Location
- Lake Oswego, OR, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,571 bottles
Reason for Recall
cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
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%).
Distribution Pattern
Nationwide in the USA and Canada.
Other Recalls by HTO Nevada, Inc.
- Class II: Risk 02/09/2023
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.