1 August 2023
TOPEKA (KSNT) – National officials are recalling a contraceptive because its effectiveness could result in unexpected pregnancy.
The U.S. Food & Drug Administration (FDA) announced Monday that a contraceptive is being recalled by Lupin Pharmaceuticals Inc. because the product’s effectiveness could potentially result in unexpected pregnancy. Tydemy, an estrogen/progestin oral contraceptive used to prevent pregnancy, was recalled due to out-of-specification results and testing low for ascorbic acid and high for a known impurity, according to the FDA.
Lots of Tydemy were distributed nationwide to U.S. wholesalers, drug chains, mail-order pharmacies and supermarkets, according to the FDA.
ProductLot numberExpiryNational Drug CodeUPCDistribution datesTydemyTML200183Jan. 202468180-904-71
(1 Blister of 28 tablets each)368180904731June 2022 to May 2023
TydemyTML201560Sep. 202468180-904-71
(1 Blister of 28 tablets each)368180904731June 2022 to May 2023
Patients taking Tydemy are advised to stop taking the medication and contact a pharmacist, physician or medical provider for alternative treatment. There are currently no reports of adverse events being related to the recalled batches. Lupin is still recalling the batches because the amount of ascorbic acid could impact the product’s effectiveness, according to the FDA.
Anyone with questions regarding the recall are asked to contact Inmar Rx Solutions, Inc. at 866-480-8206 on weekdays from 9 a.m. to 6 p.m. EST. Any adverse reactions can be reported to the FDA’s MedWatch Adverse Event Reporting program online, by mail by requesting a form at 1-800-322-1088 or by fax at 1-800-FDA-0178.