DrugJun 14, 2017
Qualgen Estradiol 20 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count and 12 recall — FDA D-0891-2017
CGMP deviations- Lack of Quality Assurance
Class IIFDA: TerminatedQualgen
Recall history in this database
Classification mix: Class II: 10.
DrugJun 14, 2017
Qualgen Estradiol 12.5 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 recall — FDA D-0894-2017
CGMP deviations- Lack of Quality Assurance
Class IIFDA: TerminatedQualgen
DrugJun 14, 2017
Qualgen Estradiol 10 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 recall — FDA D-0895-2017
CGMP deviations- Lack of Quality Assurance
Class IIFDA: TerminatedQualgen
DrugJun 14, 2017
Qualgen Estradiol 22 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 recall — FDA D-0890-2017
CGMP deviations- Lack of Quality Assurance
Class IIFDA: TerminatedQualgen
DrugJun 14, 2017
Qualgen Estradiol 18 mg pellet , 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 recall — FDA D-0892-2017
CGMP deviations- Lack of Quality Assurance
Class IIFDA: TerminatedQualgen
DrugJun 14, 2017
Qualgen Estradiol 25 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 recall — FDA D-0889-2017
CGMP deviations- Lack of Quality Assurance
Class IIFDA: TerminatedQualgen
DrugJun 14, 2017
Qualgen Estradiol 6 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count recall — FDA D-0896-2017
CGMP deviations- Lack of Quality Assurance
Class IIFDA: TerminatedQualgen
DrugJun 14, 2017
Qualgen Estradiol 15 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 recall — FDA D-0893-2017
CGMP deviations- Lack of Quality Assurance
Class IIFDA: TerminatedQualgen
DrugDec 2, 2015
Qualgen Estradiol USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 6 mg recall — FDA D-0386-2016
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.
Class IIFDA: TerminatedQualgen
DrugDec 2, 2015
Qualgen Testosterone USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 25 mg recall — FDA D-0387-2016
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.
Class IIFDA: TerminatedQualgen
Understanding this recall history
This page summarizes recall records in which the official source identifies Qualgen as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.