The Recall Desk

FDA (Drugs) recall action 68896

Fagron, Inc recalled 3 products on 2014-08-06

The FDA (Drugs) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2014-08-06
Critical
0
Units
626

Why these products were recalled

Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.

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.

1–3 of 3

  • HighFDA (Drugs)··2014-08-06

    Fagron Recalls Phytobase Cream Lots Due to Mold Contamination

    Fagron is recalling six lots of Phytobase Cream, a prescription compounding vehicle, due to the presence of mold.

    Product
    Fagron, Phytobase Cream, 500 g, Article number: 802156. RX only, For prescription compounding Natural self-emulsifying oil-in water vehicle for oil-solvents ingredients. Contains Phytosomes (Plant Oil Bodies), Manufactured by Fagron, Inc. 2400 Pilot Knob Rd, St Paul, MN 55120,
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2014-08-06

    Fagron Recalls Pentravan Plus Base Due to Mold Contamination

    Fagron is recalling specific lots of Pentravan Plus Base, a prescription compounding ingredient, because of mold contamination.

    Product
    Fagron, Pentravan Plus Base 2.5 Kg, Article number: 804749. RX only, For prescription compounding, Oil-in-water emulsion base alternative to PLO gel, Added emulsifier ad viscosity-enhancing agent for use with high concentrations of active ingredients.Pre served and fragrance-fr
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2014-08-06

    Fagron Recalls Pentravan Base Due to Mold Contamination

    Fagron is recalling six lots of Pentravan Base 2.5 Kg due to the presence of mold. The product is used for prescription compounding.

    Product
    Fagron, Pentravan Base 2.5 Kg, Article number: 802486. RX only, For prescription compounding, Oil-in-water emulsion, PLO gel alternative, Preserved and fragrance-free, Manufactured by; Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 NDC 51552-0919-8.
    Category
    Distribution
    0 states