Two types of blood pressure medications sold by Lupin Pharmaceuticals Inc. were voluntarily recalled by the manufacturer after routine ingredient testing detected high levels of N-nitrosoirbesartan, a potentially cancer-causing impurity.
The company recalled all batches of its Irbesartan tablets (75 mg, 150 mg and 300 mg) and Irbesartan-Hydrochlorothiazide (150 mg/12.5 mg and 300 mg/12.5 mg). The recalled tablets were packaged in 30- and 90-count bottles and distributed nationwide to wholesalers, drug chains, mail order pharmacies and supermarkets.
Recalled blood pressure medications
|Irbesartan Tablets, 75mg||
H000843, H805727, H901579, H000844, H000964, H804311,
H805267, H805268, H805269,
H805725, H805726, H901497,
H901577, H901578, H902258
|Irbesartan Tablets, 150 mg||H804403, H805251, H805640, H901580, H804492, H805252, H805253, H805641, H805642, H805643, H901581, H902139, H902140|
|Irbesartan Tablets, 300 mg||
H804310, H900050, H902262, H000845, H000846, H000965,
H805345, H805346, H805347,
H805724, H900061, H900062,
H900445, H901489, H901490,
|Irbesartan-Hydrochlorothiazide Tablets, 150mg/12.5mg||
H804537, H805148, H900063, H900522, H901582, H000963, H804507, H804536, H805070,
H805149, H900064, H900523, H901583, H902530
|Irbesartan-Hydrochlorothiazide Tablets, 300mg/12.5mg||
H804192, H805348, H900065, H902264, H804082, H804121, H804338, H804538, H804539, H805349, H805350, H900066,
H900067, H902265, H902275, H902276, H902531, H902532
Advice for consumers
Patients who are taking any of the recalled medications are advised to continue taking them and contact their pharmacist, physician or medical provider to discuss an alternative treatment option. Meanwhile, Lupin Pharmaceuticals is arranging the return of the recalled drugs with its distributors.
Consumers with questions should contact Inmar Rx Solutions at 855-769-3988 or 855-769-3989 Monday through Friday from 9 a.m. to 5 p.m. ET. For reimbursement, make sure the lot number matches the batches recalled (found on the side of the bottle label).
Any adverse reactions or quality problems experienced with the use of these products may be reported to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online or by mail or fax using this downloadable form.
What is N-nitrosoirbesartan?
N-nitrosoirbesartan is an impurity that is considered a “probable” human carcinogen, based on results from laboratory tests.