Lupin Pharmaceuticals Recalls Pregnancy Prevention Drug In US
Lupin Pharmaceuticals Inc., a wholly-owned subsidiary of Lupin is voluntarily recalling two lots of Tydemy to the patient 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, USFDA said in a statement on Friday.
Tydemy is an 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.
To date, Lupin has received no reports of adverse events related to either recalled batches. Regardless, Lupin is recalling these two batches 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 an unexpected pregnancy.
The lots were distributed nationwide in the US to wholesalers, drug chains, mail order pharmacies and supermarkets, USFDA said.
Lupin is notifying its wholesalers, distributors, drug chains, mail order pharmacies and supermarkets by phone and through recall notification and is arranging for the return of all the recalled product lots.
USFDA advised that patients taking Tydemy are advised to continue taking their medication and immediately contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. Whereas the top drug regulatory said that wholesalers, distributors and retailers that have Tydemy that is being recalled should discontinue distribution of the recalled product lots immediately.
