Lake Oswego, OR, United States
HTO Nevada, Inc. recalls
1 recall recorded since 2018, most recently on 9 February 2023. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Drugs
- Recall started
- 9 February 2023
- Terminated
- 17 November 2023
- Reason
- cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
- Distribution
- Nationwide in the USA and Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0271-2023, D-0270-2023
- 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 li
- 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 Code: 80069-008-01. Drug
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.