Manufacturer

Qualgen

10 recalls in our database name Qualgen as the manufacturing or recalling firm.

What the numbers show

Total: 10
Critical: 0
Severe: 2
Most recent: 2017-06-14

Of the 10 recalls from Qualgen we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (20%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–10 of 10

SevereFDA (Drugs)·D-0894-2017·2017-06-14
Qualgen Recalls Estradiol Pellets Due to Quality Assurance Deviations
Qualgen is recalling Estradiol 12.5 mg pellets due to CGMP deviations and a lack of quality assurance. The recall covers 4,883 pellets distributed nationwide.
Product
Estradiol 12.5 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013, NDC: 69761-012-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0890-2017·2017-06-14
Qualgen Recalls Estradiol Pellets Due to Quality Assurance Deviations
Qualgen is recalling Estradiol 22 mg pellets due to CGMP deviations and lack of quality assurance. The recall covers 1,666 pellets distributed nationwide.
Product
Estradiol 22 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC 69761-022-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0891-2017·2017-06-14
Qualgen Recalls Estradiol Pellets Due to Quality Assurance Deviations
Qualgen is recalling Estradiol 20 mg pellets due to CGMP deviations and lack of quality assurance. The recall covers 4,468 pellets distributed nationwide.
Product
Estradiol 20 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count and 12 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-020-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0896-2017·2017-06-14
Qualgen Estradiol Pellets Recalled for Quality Assurance Deviations
Qualgen is recalling Estradiol 6 mg pellets due to CGMP deviations and lack of quality assurance. The recall covers 4,815 pellets distributed nationwide.
Product
Estradiol 6 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by; Qualgen 14844 Bristol Park Blvd. Edmond, OK 73013 NDC: 69761-006-01.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0895-2017·2017-06-14
Qualgen Recalls Estradiol Pellets Due to Quality Assurance Deviations
Qualgen is recalling Estradiol 10 mg pellets due to CGMP deviations and lack of quality assurance. The recall covers 5,260 pellets distributed nationwide.
Product
Estradiol 10 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only , For Subcutaneous Use Only Rx Only Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-010-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0892-2017·2017-06-14
Qualgen Recalls Estradiol Pellets Due to Quality Assurance Deviations
Qualgen is recalling Estradiol 18 mg pellets due to CGMP deviations and lack of quality assurance. The recall covers 6,361 pellets distributed nationwide.
Product
Estradiol 18 mg pellet , 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-018-01.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0893-2017·2017-06-14
Qualgen Recalls Estradiol Pellets Due to Quality Assurance Deviations
Qualgen is recalling Estradiol 15 mg pellets due to CGMP deviations and lack of quality assurance. The recall covers 6,227 units distributed nationwide.
Product
Estradiol 15 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles. Sterile Office Use Only, For Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013, NDC: 69761-015-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0889-2017·2017-06-14
Qualgen Recalls Estradiol Pellets Due to Quality Assurance Deviations
Qualgen is recalling Estradiol 25 mg pellets due to CGMP deviations and lack of quality assurance. The recall covers 1,153 pellets distributed nationwide.
Product
Estradiol 25 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only. Rx Only ,Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC 69761-025-01,
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0387-2016·2015-12-02
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
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0386-2016·2015-12-02
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
Drug
Distribution
Distributed nationwide