February 07, 2019
Prinston Pharmaceutical Inc. is recalling 19,800 bottles of irbesartan tablets, 300 mg, because the carcinogenic substance N-nitrosodiethylamine (NDEA) was found in an active pharmaceutical ingredient used to manufacture the drug. The recall was announced in the February 6, 2019, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects 90-count bottles of irbesartan (NDC 43547-376-09) from lot 331B18009. The FDA did not report the expiration date of the recalled lot, which was manufactured by Zhejiang Huahai Pharmaceutical Co. and distributed by Solco Healthcare US throughout the United States.
Prinston Pharmaceutical voluntarily issued the recall January 18, 2019. On January 27, 2019, the FDA designated it Class II, in line with a slate of valsartan recalls issued over the past 9 months over the presence of NDEA. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.
Like valsartan, irbesartan is a prescription medication used to treat patients with high blood pressure. Irbesartan also protects the kidneys from diabetes-related damage.
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