Drug recall
Maximum Zone2 Topical Analgesic, 1oz bottle, for use during a pain sensitive procedure, distributed by: DERMAL…
FDA recall event 91694 · Class II · HTO Nevada, Inc.
Key facts
| Event ID | 91694 |
|---|---|
| Recall numbers | D-0270-2023, D-0271-2023 |
| Recalling firm | HTO Nevada, Inc. |
| Product type | Drugs |
| Products | 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…, 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API. |
| Initiation date | Feb 9, 2023 |
| Report date | Feb 22, 2023 |
| Termination date | Nov 17, 2023 |
| City | Lake Oswego |
| State | OR |
| Country | United States |
| FEI number | 3004268965 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: