fda
27 records
FDA Drug Recall: Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded prod
2025-07-23
Class III — Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.
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FDA Drug Recall: Testosterone 25 mg pellet, 1 count (NDC: 69761-125-01) and 30 count vials (NDC:
2018-11-14
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: Testosterone 50mg pellet, 1 count (NDC 69761-150-01), 6 count (NDC 69761-150-06)
2018-11-14
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: Estradiol 15mg pellet, 1 count (NDC 69761-015-01), 6 count (NDC 69761-015-06), 1
2018-11-14
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: Estradiol 12.5mg pellet, 1 count (NDC 69761-012-01), 6 count (NDC 69761-012-06),
2018-11-14
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: Testosterone 100mg pellet, 1 count (NDC 69761-110-01), 6 count (NDC 69761-110-06
2018-11-14
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: Testosterone 200 mg/Anastrozole 20 mg pellet, 1 count (NDC 69761-222-01), 6 coun
2018-11-14
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: Estradiol 18mg pellet, 1 count (NDC 69761-018-01), 6 count (NDC 69761-018-06), 1
2018-11-14
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: Testosterone 37.5 mg pellet, 1 count (NDC 69761-137-01), 6 count (NDC 69761-137-
2018-11-14
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: Testosterone 200mg pellet, 1 count (NDC 69761-120-01), 6 count (NDC 69761-120-06
2018-11-14
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: Testosterone 87.5mg pellet, 1 count (NDC 69761-187-01), 6 count (NDC 69761-187-0
2018-11-14
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: Estradiol 25mg pellet, 1 count (NDC 69761-025-01), 6 count (NDC 69761-025-06), 1
2018-11-14
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: Testosterone 12.5mg pellet, 1 count (NDC 69761-112-01), 6 count (NDC 69761-112-0
2018-11-14
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: Estradiol 6 mg pellet, 1 count (NDC 69761-006-01), 6 count (NDC 69761-006-06), 1
2018-11-14
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: Estradiol 10mg pellet, 1 count (NDC 69761-010-01), 6 count (NDC 69761-010-06), 1
2018-11-14
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: ESTRADIOL 20mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 1
2018-07-11
Class III — Labeling: Incorrect or Missing Lot and/or Exp Date.
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FDA Drug Recall: TESTOSTERONE 200 mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qual
2018-07-11
Class III — Labeling: Incorrect or Missing Lot and/or Exp Date.
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FDA Drug Recall: Estradiol 20 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count and 1
2017-06-14
Class II — CGMP deviations- Lack of Quality Assurance
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FDA Drug Recall: Estradiol 12.5 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12
2017-06-14
Class II — CGMP deviations- Lack of Quality Assurance
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FDA Drug Recall: Estradiol 10 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 c
2017-06-14
Class II — CGMP deviations- Lack of Quality Assurance
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FDA Drug Recall: Estradiol 22 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12
2017-06-14
Class II — CGMP deviations- Lack of Quality Assurance
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FDA Drug Recall: Estradiol 18 mg pellet , 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 1
2017-06-14
Class II — CGMP deviations- Lack of Quality Assurance
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FDA Drug Recall: Estradiol 25 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12
2017-06-14
Class II — CGMP deviations- Lack of Quality Assurance
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FDA Drug Recall: Estradiol 6 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 co
2017-06-14
Class II — CGMP deviations- Lack of Quality Assurance
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FDA Drug Recall: Estradiol 15 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 c
2017-06-14
Class II — CGMP deviations- Lack of Quality Assurance
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FDA Drug Recall: Estradiol USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 6 mg (N
2015-12-02
Class II — 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.
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FDA Drug Recall: Testosterone USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 25 m
2015-12-02
Class II — 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.
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nppes
1 records
ny_corps
1 records
NY Corp: QUALGEN, LLC
2019-08-16
FOREIGN LIMITED LIABILITY COMPANY | County: New York | Jurisdiction: Oklahoma
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