The Recall Desk

FDA (Drugs) recall action 72401

Qualgen recalled 2 products on 2015-12-02

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
2015-12-02
Critical
0
Units
15,106

Why these products were recalled

Lack of Assurance of Sterility: The firm is recalling all sterile preparations within expiry due to deficient practices which may have an impact on sterility assurance.

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)··2015-12-02

    Qualgen Recalls Estradiol Pellets Due to Sterility Assurance Concerns

    Qualgen is recalling 4,221 vials of compounded Estradiol USP pellets nationwide because deficient practices may have impacted sterility assurance.

    Product
    Estradiol USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 6 mg (NDC 69761-006-01),10 mg (NDC 69761-010-01),12.5 mg (NDC 69761-012-01), 15 mg (NDC 69761-015-01),18 mg (NDC 69761-018-01),20 mg (NDC 69761-020-01), 22 mg (NDC 69761-022-01), 25 mg (NDC 69761-025-01), Rx
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2015-12-02

    Qualgen Recalls Testosterone Pellets Due to Sterility Assurance Concerns

    Qualgen is recalling 10,885 vials of compounded Testosterone USP pellets nationwide due to deficient practices that may impact sterility assurance.

    Product
    Testosterone USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 25 mg (NDC 69761-125-01), 37.5 mg (NDC 69761-137-01), 50 mg (NDC 69761-150-01), 87.5 mg (NDC: 69761-187-01), 100 mg (NDC 69761-110-01), 200 mg (NDC 69761-120-01), Rx only, Compounded by Qualgen, Edmond, O
    Category
    Distribution
    0 states