Lupin Pharmaceuticals is voluntarily recalling two 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 patients, 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.
To date, Lupin has received no reports of adverse events related to either recalled lots. Regardless, Lupin is recalling two lots because if there were a significant reduction in the amount of inactive content (ascorbic acid), this could potentially impact the effectiveness of the product, which could potentially result in unexpected pregnancy.
Tydemy is estrogen/progestin oral contraceptive (COC) indicated for use by women to prevent pregnancy and to raise folate levels in women who choose to use an oral contraceptive for contraception. Tydemy is packaged in 28's blister. One such blister was then packed in a pouch along with one printed sleeve, one pack insert (with day label) and one oxygen absorber (Stabilox) sachet. The three pouches were packed in one carton.
The lots were distributed nationwide in the US to wholesalers, drug chains, mail order pharmacies and supermarkets.