The Recall Desk

FDA (Drugs) recall action 89797

Fagron, Inc recalled 5 products on 2022-05-18

The FDA (Drugs) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2022-05-18
Critical
0
Units
182

Why these products were recalled

Subpotent Drug

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.

1–5 of 5

  • ModerateFDA (Drugs)··2022-05-18

    FDA Recalls Subpotent Nandrolone Decanoate Compounding Ingredient

    Fagron, Inc initiated a nationwide recall of Nandrolone Decanoate compounding ingredient due to subpotency. The affected lot may contain below-strength concentrations of the active pharmaceutical ingredient.

    Product
    Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescription Compounding, Distributed by: Humco, 7400 Alumax Road, Texarkana, TX 75501. NDC 0395-8212-43
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2022-05-18

    FDA Recalls Subpotent Nandrolone Decanoate Compounding Ingredient from Fagron

    Fagron Inc. initiated a voluntary recall of 68 containers of Nandrolone Decanoate USP in March 2022 after the product was found subpotent, containing less active ingredient than labeled. The recall affects compounding pharmacies nationwide.

    Product
    Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot Knob Rd., St Paul, MN 55120. NDC 51552-1564-07
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2022-05-18

    Prescription Compounding Drug Nandrolone Decanoate Recalled for Subpotency

    Fagron, Inc. is recalling 2 containers of Nandrolone Decanoate USP used for prescription compounding because the product is subpotent, containing less active ingredient than expected. The recall is nationwide.

    Product
    Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescription Compounding, Distributed by: Humco, 7400 Alumax Road, Texarkana, TX 75501. NDC 0395-8212-56
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2022-05-18

    FDA recalls Nandrolone Decanoate compounding ingredient for subpotency nationwide

    Fagron, Inc. recalls 53 containers of Nandrolone Decanoate compounding ingredient due to subpotency. The product was distributed nationwide.

    Product
    Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot Knob Rd., St Paul, MN 55120. NDC 51552-1564-05
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2022-05-18

    Fagron recalls Nandrolone Decanoate USP for subpotency in multiple lots

    Fagron, Inc. is recalling 58 containers of Nandrolone Decanoate USP for prescription compounding due to subpotency. The affected lots were distributed nationwide.

    Product
    Nandrolone Decanoate, USP, 100 g per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot Knob Rd., St Paul, MN 55120. NDC 51552-1564-04
    Category
    Distribution
    0 states