All batches of Irbesartan tablets in 75 mg, 150 mg and 300 mg strengths and Irbesartan and Hydrochlorothiazide tablets in 150 mg/12.5 mg and 300 mg/12.5 mg strengths made by Lupin Pharmaceuticals have been recalled.
Lupin’s FDA-posted recall notice said “certain tested [active pharmaceutical ingredient] batches (but not finished product batches) were above the specification limit for the impurity, N-nitrosoirbeartan.”
Lupin said it discontinued marketing the tablets, used to treat hypertension (high blood pressure), in January.
Here’s what you need to know.
What’s being recalled?
▪ Irbesartan, 75 mg, 30-count bottles with lot Nos. H000843, H805727 and H901579 and 90-count bottles with lot Nos. H000844, H000964, H804311, H805267, H805268, H805269, H805725, H805726, H901497, H901577, H901578, and H902258.
▪ Irbesartan, 150 mg, 30-count bottles with lot Nos. H804403, H805251, H805640, and H901580 and 90-count bottles with lot Nos. H804492, H805252, H805253, H805641, H805642, H805643, H901581, H902139, and H902140.
▪ Irbesartan, 300 mg, 30-count bottles with lot Nos. H804310, H900050 and H902262 and 90-count bottles with lot Nos. H000845, H000846, H000965, H805345, H805346, H805347, H805724, H900061, H900062, H900445, H901489, H901490, H901491 and H902261.
▪ Irbesartan and Hydrochlorothiazide, 150 mg/12.5 mg, 30-count bottles with lot Nos. H804537, H805148,H900063, H900522, and H901582 and 90-count bottles with lot Nos. H000963, H804507, H804536, H805070, H805149, H900064, H900523, H901583, and H902530.
▪ Irbesartan and Hydrochlorothiazide, 300 mg/12.5 mg, 30-count bottles with lot Nos. H804192, H805348, H900065 and H902264 and 90-count bottles with lot Nos. H804082, H804121, H804338, H804538, H804539, H805349, H805350, H900066, H900067, H902265, H902275, H902276, H902531 and H902532.
What’s the problem with Irbesartan and Irbesartan and Hydrochlorothiazide?
Lab tests say the N-nitrosoirbesartan impurity is a “probable human carcinogen.”
Lupin says from Oct. 8, 2018, through Sept. 30 of this year, it heard of four people getting sick from Irbesartan, but those illnesses weren’t related to the N-nitrosoirbesartan.
What do you do now?
If you’re a patient taking either drug, keep taking it until you and your doctor or pharmacist come up with a new treatment.
If you’re a wholesaler or retailer, box up the recalled tablets you have left and send them to Inmar Rx Solutions, Inc., 635 Vine St, Winston Salem, NC, 27101.
Anyone with questions should call Inmar at 855-769-3988 or 855-769-3989, Monday through Friday, 9 a.m. to 5 p.m., Eastern time.
If this or any drug causes a problem, after notifying a medical professional, let the FDA know via its MedWatch Adverse Event page or by filling out a form you can get by calling 800-332-1088.