EPINEPHRINE Recall D-0271-2023
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%).
EPINEPHRINE Recall D-0271-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0271-2023 |
| Event ID | 91694 |
| Brand | ZONE 2 |
| Generic Name | LIDOCAINE HCL, EPINEPHRINE |
| Manufacturer | LIDOCAINE HCL, EPINEPHRINE |
| Original Package? | 1 |
| Active Substance | EPINEPHRINE LIDOCAINE HYDROCHLORIDE |
| Drug Route | TOPICAL |
| Distribution | Nationwide in the USA and Canada. |
| Quantity | 1,571 bottles |
| Recall Reason | cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API. |
| Drug Classification | Class II |
| Drug Code Info | 20230222 |
| Product NDC | 80069-012 |
| Product NUI | N0000000209 N0000000245 N0000175552 |
| Pharma Class (EPC) | alpha-Adrenergic Agonist [EPC] |
| Pharma Class (CS) | Catecholamines [CS] |
| Recall Initiation Date | 20230209 |
| Report Date | 20230222 |
| Classification Date | 20230215 |
| Address | 6400 Rosewood St Lake Oswego, OR 97035-5392 United States |
| Recalling Firm | HTO Nevada, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | YKH834O4BH V13007Z41A |
| Drug Application Number | part348 |
| Structured Product Labeling (SPL ID) | 7d54be42-f9f7-4995-a73f-023b53cc9346 |
| Structured Product Labeling (SPL Set ID) | 46eb6929-8fbd-4be8-b772-603f1419f1ea |
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