Lupin Pharma Recalls Tydemy Oral Contraceptive

Baltimore, Maryland-based Lupin Pharmaceuticals, Inc. has recalled 2 lots of Tydemy oral contraceptive citing out of specification or OOS test results at the 12-month stability time point, according to the U.S. Food and Drug Administration. Specifically, one lot was tested low for ascorbic acid, which is an inactive ingredient, and high for a known impurity.

The recall involves Tydemy (Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets 3mg/0.03mg/0.451 mg and Levomefolate Calcium Tablets 0.451 mg) to the patient level.

Tydemy is estrogen/progestin oral contraceptive or 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.

According to the agency, a significant reduction in the amount of inactive content, such as ascorbic acid, could potentially impact the effectiveness of the product which could potentially result in unexpected pregnancy. Lupin has not received any reports of adverse events related to either recalled batches to date.

Tydemy is packaged in 28’s blister, and one such blister was then packed in a pouch. The three pouches were packed in one carton.

The affected products come with lot no. L200183 with expiry date of January 2024, and lot no. L201560 with expiry date of September 2024. The products with UPC 368180904731 were distributed between June 2022 and May 2023 in the US to wholesalers, drug chains, mail order pharmacies and supermarkets.

Lupin is notifying all and is arranging for the return of all the recalled product lots.

The FDA has asked patients taking Tydemy to continue taking their medication, and also to immediately seek advice regarding an alternative treatment.

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