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%).
Reported: February 22, 2023 Initiated: February 9, 2023 #D-0271-2023
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.
Details
- Recalling Firm
- HTO Nevada, Inc.
- Units Affected
- 1,571 bottles
- Distribution
- Nationwide in the USA and Canada.
- Location
- Lake Oswego, OR
Frequently Asked Questions
What product was recalled? ▼
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%).. Recalled by HTO Nevada, Inc.. Units affected: 1,571 bottles.
Why was this product recalled? ▼
cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 22, 2023. Severity: Moderate. Recall number: D-0271-2023.
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