February 07, 2019
Prinston Pharmaceutical Inc. is recalling four lots of irbesartan and hydrochlorothiazide tablets, USP, after discovering the carcinogenic substance N-nitrosodiethylamine (NDEA) in an active pharmaceutical ingredient used to manufacture the drug. The recall appeared in the February 6, 2019, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects the following products, which were manufactured by Zhejiang Huahai Pharmaceutical Co. and distributed by Solco Healthcare US:
- 30-count bottles of irbesartan and hydrochlorothiazide tablets, 150/12.5 mg (NDC 43547-330-03), from lots 325D18004 and 325D18005;
- 90-count irbesartan and hydrochlorothiazide tablets, 150/12.5 mg (NDC 43547-330-09), from lot 325B18004;
- 30-count irbesartan and hydrochlorothiazide tablets, 300/12.5 mg (NDC 43547-331-03), from lots 327A18001 and 327A18002; and
- 90-count bottles irbesartan and hydrochlorothiazide tablets, 300/12.5 mg (NDC 43547-331-09), from lots 327B18008 and 327B18009.
The recalled lots were distributed throughout the United States.
Prinston Pharmaceutical voluntarily issued the recall January 18, 2019. Similar to numerous valsartan recalls issued over the past 9 months after the presence of NDEA, the FDA designated Prinston Pharmaceutical’s irbesartan-hydrochlorothiazide recall Class II on January 27, 2019. Under Class II recalls, use of the product could cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm.
Like valsartan, irbesartan is a prescription medication used to treat patients with high blood pressure. Hydrochlorothiazide is a diuretic.
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