Two Lots of Oral Contraceptives Recalled

Lupin Pharmaceuticals has voluntarily recalled 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 test results at the 12-month stability time point. 

Tydemy is indicated to prevent pregnancy and to raise folate levels in women who choose to use an oral contraceptive for contraception. The recalled products were distributed nationwide to wholesalers, drug chains, mail order pharmacies and supermarkets between June 2022 to May 2023, and include lot numbers L200183 (Expiry Date January 2024; NDC Number 68180-904-71) and L201560 (Expiry Date September 2024; NDC Number 68180-904-73).

Lot number L200183 was specifically found to have low levels of ascorbic acid (an inactive ingredient) and high levels of a known impurity. According to the Company, a significant reduction in the amount of inactive content could potentially impact the effectiveness of the product, which could potentially result in unexpected pregnancy. To date, there have been no reports of adverse events related to the recall.

Individuals with questions related to this recall can call Inmar Rx Solutions, Inc. at (866) 480-8206. Adverse events or quality issues should be reported to the FDA’s MedWatch Adverse Event Reporting program.

This article originally appeared on MPR