All lots of 75 mg, 150 mg and 300 mg irbesartan tablets and 150 mg / 12.5 mg and 300 mg / 12.5 mg irbesartan and hydrochlorothiazide tablets manufactured by Lupine Pharmaceuticals were recalled.
The FDA-issued recall notice of Lupine read “some tested [active pharmaceutical ingredient] lots (but not the finished product lots) were above the specification limit for the impurity, N-nitrosoirbeartan.
Lupine said he stopped marketing the tablets, used to treat hypertension (high blood pressure), in January.
Here’s what you need to know.
What is recalled?
▪ Irbesartan, 75 mg, 30-unit vials with lot numbers H000843, H805727 and H901579 and 90-unit vials with lot numbers H000844, H000964, H804311, H805267, H805268, H805269, H805725, H805726, H901497, H907815 , and H902258.
▪ Irbesartan, 150 mg, vials of 30 units with lot numbers H804403, H805251, H805640 and H901580 and vials of 90 units with lot numbers H804492, H805252, H805253, H805641, H805642, H805643, H901581 and, H90240.
▪ Irbesartan, 300 mg, 30 unit vials with lot numbers H804310, H900050 and H902262 and 90 unit vials with lot numbers H000845, H000846, H000965, H805345, H805346, H805347, H805724, H900061, H900062, H901400 , H901490, H901491 and H902261.
▪ Irbesartan and hydrochlorothiazide, 150 mg / 12.5 mg, vials of 30 units with lot numbers H804537, H805148, H900063, H900522, and H901582 and vials of 90 units with lot numbers H000963, H804507, H804536, H805070, H805149 , H900064, H900523, H901583 and H902530.
▪ Irbesartan and hydrochlorothiazide, 300 mg / 12.5 mg, vials of 30 units with lot numbers H804192, H805348, H900065 and H902264 and vials of 90 units with lot numbers H804082, H804121, H804338, H804538, H804539, H805349, H805350, H900066, H900067, H902265, H902275, H902276, H902531 and H902532.
What’s wrong with irbesartan and irbesartan and hydrochlorothiazide?
Laboratory tests indicate that the impurity N-nitrosoirbesartan is “possibly carcinogenic to humans”.
Lupine says that from October 8, 2018 to September 30 of this year, he heard about four people who got sick from irbesartan, but these illnesses were not related to N-nitrosoirbesartan.
What are you doing now?
If you are a patient taking either of these medicines, keep taking them until you and your doctor or pharmacist suggest a new treatment.
If you are a wholesaler or retailer, pack any remaining recalled tablets and ship 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. EST.
If this or another drug is causing a problem, after notifying a healthcare practitioner, notify the FDA through its MedWatch Adverse Events page or by filling out a form which you can get by calling 800-332-1088. .