December 21, 2018
Westminster Pharmaceuticals is recalling irbesartan tablets, USP, manufactured by ScieGen Pharmaceuticals because the probable carcinogen N-nitrosodiethylamine (NDEA) was detected in the drug, according to the December 19, 2018, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects the following products, which were distributed throughout the United States:
- 75-mg irbesartan tablets, in 30-count bottles (NDC 69367-119-01) from lot B160002A (Exp. 9/30/19) and 90-count bottles (NDC 69367-119-03) from lot B160002B (Exp. 9/30/19);
- 150-mg irbesartan tablets in 30-count bottles (NDC 69367-120-01) from lots B161005A (Exp. 9/30/19) and C161002A (Exp. 2/29/20) and 90-count bottles (NDC 69367-120-03) from lots B161005B (Exp. 9/30/19) and C161002B (Exp. 2/29/20); and
- 300-mg irbesartan tablets in 30-count bottles (NDC 69367-121-01) from lots B162008A (Exp. 9/30/19) and C162002A (Exp. 2/29/20) and 90-count bottles (NDC 69367-121-03) from lots B162008B (Exp. 9/30/19) and C162002B (Exp. 2/29/20).
Westminster Pharmaceuticals initiated the voluntary recall October 29, 2018. On December 14, 2018, the FDA designated the recall Class II. The classification warns use of the affected drugs may cause temporary or medically reversible adverse health consequences. While remote, a possibility of serious harm also exists.
Irbesartan is a prescription medication indicated for the treatment of hypertension.
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