Class II · Moderate risk Ongoing
Norgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg, 3 Units, 3x28 tablets…
Reason Failed Content Uniformity Specifications
Is Norgestimate recalled?
4 FDA recalls mention Norgestimate. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Norgestimate.
Class II · Moderate risk Terminated
Tri-Lo-Sprintec (norgestimate and ethinyl estradiol) tablets USP - triphasic regimen, packaged in carton containing 3 Blister…
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets, USP), 0.180 mg/0.025 mg; 0.215mg/0.025 mg and 0.250 mg/0.025 mg, Pack…
Reason CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data.
Class II · Moderate risk Terminated
Estarylla (Norgestimate and Ethinyl Estradiol) Tablets. USP, 0.25mg/0.035mg, 3X28 tablets per carton. Rx only, Manufactured by…
Reason Contraceptive Tablets out of Sequence: A placebo tablet was found in a row of active tablets.
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