Maximum Zone2 Topical Analgesic recall: CGMP Deviations
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%).
Why was Maximum Zone2 Topical Analgesic recalled?
cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 795CP-0003, Exp 07/2024.
- Product
- 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%).
- Recalling firm
- HTO Nevada, Inc.
- Quantity
- 1,571 bottles
- Distribution
- Nationwide in the USA and Canada.
- Recall date
- February 22, 2023
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)