RELATED: If You Use This Medication, Throw It Away Now, FDA Says.
On Oct. 14, the FDA announced that Baltimore, Maryland-based Lupin Pharmaceuticals Inc. had voluntarily recalled select batches of its Irbesartan Tablets and Irbesartan and Hydrochlorothiazide Tablets USP, medications commonly used to control high blood pressure.ae0fcc31ae342fd3a1346ebb1f342fcb The affected medications include 75-mg. Irbesartan Tablets USP with NDC numbers 68180-410-06 and 68180-410-09, 150-mg. Irbesartan Tablets USP with NDC numbers 68180-411-06 and 68180-411-09, and 300-mg. Irbesartan Tablets USP with NDC numbers 68180-412-06 and 68180-412-09, all of which were distributed on Oct. 10, 2018 and Dec. 3, 2020. The recall also affects 150-mg./12.5-mg. Irbesartan and Hydrochlorothiazide Tablets USP with NDC numbers 68180-413-06 and 68180-413-09 and 300-mg./12.5-mg. Irbesartan and Hydrochlorothiazide Tablets USP with NDC numbers 68180-414-06 and 68180-414-09, both of which were distributed on Oct. 17, 2018 and Nov. 18, 2020. The medications were made available to consumers through drugstores, supermarkets, wholesalers, and mail-order pharmacies. For the latest recall news delivered straight to your inbox, sign up for our daily newsletter! The recall was initiated after it was discovered that the medications may have levels of N-nitroso irbesartan that exceed acceptable limits for human consumption. “N-nitroso irbesartan impurity is a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests,” the recall notice explains. Between Oct. 8, 2018 and Sept. 30, 2021, Lupin Pharmaceuticals received four reports of individuals becoming ill after taking Irbesartan and no reported illnesses associated with Irbesartan and Hydrochlorothiazide. Lupin Pharmaceuticals has not marketed either medication since Jan. 17, 2021 and is notifying distributors of both medications about the recall and coordinating the return of the affected prescriptions. Despite the potential impurity, individuals prescribed the recalled medications are advised to continue taking them until a healthcare professional can implement an alternate treatment plan. If you have questions related to the recall, contact Inmar Rx Solutions, Inc. at (855) 769-3988 or (855) 769-3989 on weekdays from 9 a.m. to 5 p.m. The recalled medications can also be returned to Inmar Rx Solutions for a refund. RELATED: If You Use Any of These OTC Medications, Throw Them Out Now, Maker Says.
