Recall alert: Lupin Pharmaceuticals recalls irbesartan
Lupin Pharmaceuticals and the Food and Drug Administration have announced a recall of batches of irbesartan tablets and irbesartan hydrochlorothiazide tablets, used to treat high blood pressure.
Some batches of the drugs had higher than the approved limit of N-nitrosoirbesartan, “a probable human carcinogen.”
The higher than acceptable levels were found in batches of unfinished medication, the FDA said.
The medication was shipped starting Oct. 18, 2018, through Sept. 30, 2021.
Lupin has received four reports of illnesses from irbesartan use, but none from the irbesartan hydrochlorothiazide medication.
The following batches of irbesartan tablets are being recalled:
| Product | Lot No. | NDC | Distribution dates |
|---|---|---|---|
| Irbesartan Tablets USP, 75mg | H000843, H805727, H901579 | 68180-410-06 (30’s | 10/20/2018
– 12/03/2020 |
| H000844, H000964, H804311,
H805267, H805268, H805269, H805725, H805726, H901497, H901577, H901578, H902258 |
68180-410-09 (90’s | 10/20/2018
– 12/03/2020 |
|
| Irbesartan Tablets USP, 150mg | H804403, H805251, H805640,
H901580 |
68180-411-06 (30’s | 10/20/2018
– 12/03/2020 |
| H804492, H805252, H805253,
H805641, H805642, H805643, H901581, H902139, H902140 |
68180-411-09 (90’s | 10/20/2018
– 12/03/2020 |
|
| Irbesartan Tablets USP, 300mg | H804310, H900050, H902262 | 68180-412-06 (30’s | 10/20/2018
– 12/03/2020 |
| H000845, H000846, H000965,
H805345, H805346, H805347, H805724, H900061, H900062, H900445, H901489, H901490, H901491, H902261 |
68180-412-09 (90’s | 10/20/2018
– 12/03/2020 |
The following batches of irbesartan and hydrochlorothiazide tablets are being recalled:
| Product | Lot No. | NCD | Distribution Dates |
|---|---|---|---|
| Irbesartan and
Hydrochlorothiazide Tablets USP, 150mg/12.5mg |
H804537, H805148,
H900063, H900522, H901582 |
68180-413-06 (30’s | 10/17/2018
– 11/18/2020 |
| H000963, H804507,
H804536, H805070, H805149, H900064, H900523, H901583, H902530 |
68180-413-09 (90’s | 10/17/2018
– 11/18/2020 |
|
| Irbesartan and
Hydrochlorothiazide Tablets USP, 300mg/12.5mg |
H804192, H805348,
H900065, H902264 |
68180-414-06 (30’s | 10/17/2018
– 11/18/2020 |
| H804082, H804121,
H804338, H804538, H804539, H805349, H805350, H900066, H900067, H902265, H902275, H902276, H902531, H902532 |
68180-414-09 (90’s | 10/17/2018
– 11/18/2020 |
Patients who are prescribed the medication are being advised to continue taking it, but to contact their pharmacy, doctor or other medical provider for an alternative treatment.
If you have questions, you can call Inmar Rx Solutions at 855-769-3988 or 855-769-3989, Monday through Friday 9 a.m. to 5 p.m. EST.
