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Qualgen, LLC

FDA Regulatory Profile

Summary

Total Recalls
27
510(k) Clearances
0
Inspections
6
Compliance Actions
2

Recent Recalls

NumberClassProductDate
D-0517-2025Class IIITestosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded product. Qualgen 14844 BJune 16, 2025
D-0225-2019Class IIEstradiol 10mg pellet, 1 count (NDC 69761-010-01), 6 count (NDC 69761-010-06), 12 count (NDC 69761-0October 17, 2018
D-0230-2019Class IIEstradiol 6 mg pellet, 1 count (NDC 69761-006-01), 6 count (NDC 69761-006-06), 12 count (NDC 69761-0October 17, 2018
D-0233-2019Class IITestosterone 200mg pellet, 1 count (NDC 69761-120-01), 6 count (NDC 69761-120-06), 12 count (NDC 697October 17, 2018
D-0238-2019Class IITestosterone 200 mg/Anastrozole 20 mg pellet, 1 count (NDC 69761-222-01), 6 count (NDC 69761-222-06)October 17, 2018
D-0232-2019Class IITestosterone 12.5mg pellet, 1 count (NDC 69761-112-01), 6 count (NDC 69761-112-06), 12 count (NDC 69October 17, 2018
D-0236-2019Class IITestosterone 50mg pellet, 1 count (NDC 69761-150-01), 6 count (NDC 69761-150-06), 12 count (NDC 6976October 17, 2018
D-0234-2019Class IITestosterone 25 mg pellet, 1 count (NDC: 69761-125-01) and 30 count vials (NDC: 69761-125-30), Rx OnOctober 17, 2018
D-0235-2019Class IITestosterone 37.5 mg pellet, 1 count (NDC 69761-137-01), 6 count (NDC 69761-137-06), 12 count (NDC 6October 17, 2018
D-0229-2019Class IIEstradiol 25mg pellet, 1 count (NDC 69761-025-01), 6 count (NDC 69761-025-06), 12 count (NDC 69761-0October 17, 2018
D-0237-2019Class IITestosterone 87.5mg pellet, 1 count (NDC 69761-187-01), 6 count (NDC 69761-187-06), 12 count (NDC 69October 17, 2018
D-0227-2019Class IIEstradiol 15mg pellet, 1 count (NDC 69761-015-01), 6 count (NDC 69761-015-06), 12 count (NDC 69761-0October 17, 2018
D-0226-2019Class IIEstradiol 12.5mg pellet, 1 count (NDC 69761-012-01), 6 count (NDC 69761-012-06), 12 count (NDC 69761October 17, 2018
D-0228-2019Class IIEstradiol 18mg pellet, 1 count (NDC 69761-018-01), 6 count (NDC 69761-018-06), 12 count (NDC 69761-0October 17, 2018
D-0231-2019Class IITestosterone 100mg pellet, 1 count (NDC 69761-110-01), 6 count (NDC 69761-110-06), 12 count (NDC 697October 17, 2018
D-0892-2018Class IIIESTRADIOL 20mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park BlJune 8, 2018
D-0893-2018Class IIITESTOSTERONE 200 mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol PaJune 8, 2018
D-0894-2017Class IIEstradiol 12.5 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 countApril 19, 2017
D-0890-2017Class IIEstradiol 22 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 count, and 30 count April 19, 2017
D-0892-2017Class IIEstradiol 18 mg pellet , 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 counApril 19, 2017