The Recall Desk

FDA (Drugs) recall action 91694

HTO Nevada, Inc. recalled 2 products on 2023-02-22

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2023-02-22
Critical
0
Units
6,280

Why these products were recalled

cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • HighFDA (Drugs)··2023-02-22

    New & Improved Blue Gel Anesthetic Recalled Nationwide for API Discoloration

    HTO Nevada, Inc. is recalling 4,709 bottles of New & Improved Blue Gel Anesthetic nationwide due to discoloration of the epinephrine active pharmaceutical ingredient resulting from a cGMP deviation in the raw material supply.

    Product
    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 Facts- For use by licensed professionals only, Active Ingre
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-02-22

    FDA Recalls Maximum Zone2 Topical Analgesic Due to Epinephrine Discoloration

    HTO Nevada's Maximum Zone2 Topical Analgesic (1oz, Lot #795CP-0003, NDC 80069-012-01) is recalled nationwide in the USA and Canada due to discoloration of the epinephrine active ingredient caused by a manufacturing deviation.

    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
    Category
    Distribution
    0 states