Class II · Moderate risk Ongoing
Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl Estradiol Tablets, USP, 0.01 mg, 3 Blisters each…
Reason Failed Impurities/Degradation Specifications
Is Desogestrel recalled?
9 FDA recalls mention Desogestrel. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Desogestrel.
Class III · Low risk Terminated
Bekyree (desogestrel and ethinyl estradiol tablets USP, 0.15 mg/0.02 mg and ethinyl estradiol tablets USP, 0.01 mg), packaged in…
Reason Failed Content Uniformity Specifications: Out Of Specification test results observed for content and blend uniformity.
Class II · Moderate risk Terminated
Ortho-Cept (0.15 mg desogestrel and 0.03 mg ethinyl estradiol) tablets, 28- count blister (21 active tablets and 7 placebo…
Reason Subpotent Drug
Class III · Low risk Terminated
Velivet (desogestrel and ethinyl estradiol tablets - triphasic regimen), 0.1 mg/0.025 mg; 0.125 mg/0.025 mg; 0.15 mg/0.025 mg…
Reason Failed Impurities/Degradation Specifications: out of specification impurity test results.
Class III · Low risk Terminated
Kariva (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28…
Reason Failed Impurities/Degradation Specifications: out of specification impurity test results.
Class III · Low risk Terminated
Mircette (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28…
Reason Failed Impurities/Degradation Specifications: out of specification impurity test results.
Class III · Low risk Terminated
Apri (desogestrel and ethinyl estradiol tablets USP), 0.15 mg/0.03 mg, 6 Cyclic dispensers X 28 tablets, Rx only, Teva…
Reason Failed Impurities/Degradation Specifications: out of specification impurity test results.
Class III · Low risk Terminated
Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen), 0.1 mg/0.025 mg, 0.125 mg/0.025 mg, 0.15 mg/0.025…
Reason Impurities/Degradation Products: Out-of-specification results were obtained for a known impurities.
Class III · Low risk Terminated
Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen), 0.1 mg/0.025 mg, 0.125 mg/0.025 mg, 0.15 mg/0.025…
Reason Impurities/Degradation Products: High Out-of-specification results were obtained for both known and unknown impurities.
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