The Recall Desk

FDA (Drugs) recall action 77060

Fagron, Inc recalled 2 products on 2017-05-31

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
2017-05-31
Critical
0
Units
—

Why these products were recalled

cGMP Deviations: lack of quality assurance at the API manufacturer.

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

1–2 of 2

  • ModerateFDA (Drugs)··2017-05-31

    Fagron Recalls Estrone Compounding Powder Due to Quality Assurance Deviations

    Fagron, Inc. is recalling Estrone for Prescription Compounding due to lack of quality assurance at the API manufacturer.

    Product
    Estrone, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-0445-1), b) 5 G bottle (NDC 51552-0445-2), c) 25 G bottle (NDC: 51552-0445-4), d) 100 G bottle (NDC: 51552-0445-5), RX only, Distributed by Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel. 1-(8
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2017-05-31

    Fagron Recalls Estriol Compounding Powder Due to Quality Assurance Deviations

    Fagron, Inc. is recalling Estriol for prescription compounding due to lack of quality assurance at the API manufacturer.

    Product
    Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-1392-1), b) 5 G bottle (NDC: 51552-1392-2), c) 25 G bottle (NDC: 51552-1392-3), d) 100 G bottle (NDC: 51552-1392-5), RX only, Distributed by Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel. 1-(8
    Category
    Distribution
    0 states