Irbesartan & Irbesartan/Hctz Recall – IMMEDIATE ACTION NEEDED
Date: | October 21, 2021 |
To: | Health Plan of San Joaquin (HPSJ) Pharmacies and Providers & Practices |
From: | HPSJ Pharmacy Department |
Subject: | Irbesartan & Irbesartan/Hctz Recall – IMMEDIATE ACTION NEEDED |
Business: | Medi-Cal Managed Care |
We are sending this alert because you may have one or more patients who filled a prescription for Irbesartan Tablets or Irbesartan/Hydrochlorothiazide Tablets within the last six months (180 days).
Lupin Pharmaceuticals Inc. is voluntarily recalling the below mentioned batches of Irbesartan Tablets and Irbesartan/Hydrochlorothiazide Tablets to the consumer level because testing revealed that certain API batches (though not finished product batches) were above the specification limit for the impurity N-nitrosoirbesartan.
Risk Statement: N-nitrosoirbesartan impurity is a probable human carcinogen (asubstance that could cause cancer) based on results from laboratory tests.
This table shows the products subject to this recall.
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 | ||
Irbesartan Tablets USP, 150mg | H804403, H805251, H805640, H901580 | 68180-411-06(30’s | |
H804492, H805252, H805253, H805641, H805642, H805643, H901581, H902139, H902140 | 68180-411-09(90’s | ||
Irbesartan Tablets USP, 300mg | H804310, H900050, H902262 | 68180-412-06(30’s | |
H000845, H000846, H000965, H805345, H805346, H805347, H805724, H900061, H900062, H900445, H901489, H901490, H901491, H902261 | 68180-412-09(90’s | ||
Irbesartan and Hydrochlorothiazide Tablets USP 150mg/12.5mg | H804537, H805148, H900063, H900522, H901582 | 68180-413-06(30’s | |
H000963, H804507, H804536, H805070, H805149, H900064, H900523, H901583, H902530 | 68180-413-09(90’s | ||
Irbesartan and Hydrochlorothiazide Tablets USP, 300mg/12.5mg | H804192, H805348, H900065, H902264 | 68180-414-06(30’s | |
H804082, H804121, H804338, H804538, H804539, H805349, H805350, H900066, H900067, H902265, H902275, H902276, H902531, H902532 | 68180-414-09(90’s |
If you have questions, please contact our HPSJ Customer Service team at 1.888.936.PLAN (7526).