FDA (Drugs) recall action 77064

Qualgen recalled 8 products on 2017-06-14

The FDA (Drugs) publishes a recall like this one as 8 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 8 pages.

Products: 8
Announced: 2017-06-14
Critical: 0
Units: 34,833

Why these products were recalled

CGMP deviations- Lack of Quality 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.

1–8 of 8

ModerateFDA (Drugs)··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.
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0 states
ModerateFDA (Drugs)··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,
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0 states
ModerateFDA (Drugs)··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.
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Distribution
0 states
ModerateFDA (Drugs)··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
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0 states
SevereFDA (Drugs)··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
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Distribution
0 states
ModerateFDA (Drugs)··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
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Distribution
0 states
ModerateFDA (Drugs)··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
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Distribution
0 states
SevereFDA (Drugs)··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
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0 states