Why it was recalled
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%).
Lot numbers, UPCs & expiration codes
Lot #: 795CP-0003, Exp 07/2024.
Where it was sold
Nationwide in the USA and Canada.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0271-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 9, 2023
- FDA report date
- Feb 22, 2023
- Quantity
- 1,571 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- HTO Nevada, Inc.
Original FDA data
Every field from FDA enforcement report D-0271-2023, exactly as published.
Show all FDA fields
- City
- Lake Oswego
- State
- OR
- Status
- Terminated
- Country
- United States
- Event ID
- 91694
- Address
- 6400 Rosewood St
- Code information
- Lot #: 795CP-0003, Exp 07/2024.
- Postal code
- 97035-5392
- Report date
- Feb 22, 2023
- Product type
- Drugs
- Recall number
- D-0271-2023
- Classification
- Class II
- Recalling firm
- HTO Nevada, Inc.
- Product quantity
- 1,571 bottles
- Termination date
- Nov 17, 2023
- Reason for recall
- cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Recall initiation date
- Feb 9, 2023
- Initial firm notification
- Letter
- Center classification date
- Feb 15, 2023