In January 2019, Prinston Pharmaceutical Inc. recalled tablets of irbesartan and irbesartan co-formulated with hydrochlorothiazide. The recall affects 1 lot of irbesartan and 7 lots of irbesartan-hydrochlorothiazide. One of the raw ingredients, irbesartan, USP, made by Zhejiang Huahai Pharmaceutical Co. contains the contaminant N-nitrosodiethylamine (NDEA). In October 2018, Sciegen Pharmaceuticals voluntarily recalled several unexpired lots of irbesartan tablets labeled for Westminster Pharmaceuticals and Golden State Medical Supply, Inc (GSMS). Sciegen Pharmaceuticals manufactured the recalled tablets using the raw ingredient, irbesartan, USP, supplied by Aurobindo Pharma Limited. Aurobindo Pharma Limited issued an earlier recall of irbesartan, USP, due to contamination with N-Nitrosodiethylamine (NDEA). The International Agency for Research on Cancer recognizes NDEA as a probable human carcinogen. Irbesartan is a medication used to treat hypertension as well as nephropathy in patients with type 2 diabetes mellitus. No adverse events related to NDEA contamination have been reported.
Pharmacies are to quarantine affected products and return products according to the individual supplier instructions. Patients should contact their healthcare provider prior to stopping their medications, since the risk of stopping the medication abruptly may be greater than the potential effects of the impurity. Consumers with questions regarding the recall may contact Prinston Pharmaceutical Inc. via telephone at 888-871-7116 or by email at customerservice@solcohealthcare.com; Aurobindo Pharma Limited at 732-839-4380; Westminster’s Regulatory Affairs via telephone at 888-354-9939; or Golden State Medical Supply Incorporated via telephone at 800-284-8633. Adverse effects should be reported to FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/medwatch/report.htm.
In April 2019, the FDA published a list of currently marketed ARB presentations and their nitrosamine assessment. The FDA plans to continually update this list as new information becomes available. The list can be found at https://www.fda.gov/drugs/drug-safety-and-availability/fdas-assessment-currently-marketed-arb-drug-products.
Additional information is available at the following links, including affected batch, NDC, and lot numbers:
- List of recalled angiotensin II receptor blockers (ARBs)
https://www.fda.gov/drugs/drug-safety-and-availability/search-list-recalled-angiotensin-ii-receptor-blockers-arbs-including-valsartan-losartan-and - Prinston Pharmaceutical Inc. Press Release – January 18, 2019
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/prinston-pharmaceutical-inc-issues-voluntary-nationwide-recall-irbesartan-and-irbesartan-hctz - Aurobindo Pharma Limited Press Release – October 26, 2018
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/aurobindo-pharma-limited-issues-voluntary-recall-irbesartan-drug-substance-due-detection-trace - FDA overview of angiotensin II receptor blocker (ARB) recalls
https://www.fda.gov/drugs/drug-safety-and-availability/recalls-angiotensin-ii-receptor-blockers-arbs-including-valsartan-losartan-and-irbesartan - FDA updates on angiotensin II receptor blocker (ARB) recalls
https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-angiotensin-ii-receptor-blocker-arb-recalls-valsartan-losartan - FDA Q&A on impurities found in ARB products
https://www.fda.gov/drugs/drug-safety-and-availability/more-questions-and-answers-impurities-found-certain-angiotensin-ii-receptor-blocker-arb-products