[August 1, 2023] FDA is warning consumers that two lots of Tydemy (drospirenone/ethinyl estradiol/levomefolate calcium), a prescription oral contraceptive (birth control pill) manufactured by Lupin Pharmaceuticals, may have reduced effectiveness due to decreased levels of ascorbic acid, an ingredient, in the product.
Lupin Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of 2 Lots of Tydemy™ (Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets 3mg/0.03mg/0.451mg and Levomefolate Calcium Tablets 0.451mg) Due to Out of Specification (OOS) Results at the 12-month Stability Time Point
BALTIMORE, Md, July 29, 2023 /PRNewswire/ --Lupin Pharmaceuticals Inc. (Lupin) is voluntarily recalling two (2) lots of Tydemy (Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets 3mg/0.03mg/0.451 mg and Levomefolate Calcium Tablets 0.451 mg) to the patient (consumer/user) level due to out of specification (OOS) test results at the 12-month stability time point. Specifically, one lot (L200183) tested low for ascorbic acid (an inactive ingredient) and high for a known impurity.
Homegrown drug maker Lupin NSE 0.01 % is recalling 4,113 cartons of generic oral contraceptive tablets in the US, the world's largest market for medicines, due to manufacturing issues. As per the latest enforcement report issued by the US Food and Drug Administration (USFDA), Lupin's US-based unit is recalling 4,113 cartons of Tydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets.
Enforcement Report - Week of December 08, 2021