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More Hypertension Drugs Recalled Over Carcinogen Presence


November 30, 2018

Various lots of irbesartan tablets are being recalled because the probable carcinogen N-Nitrosodiethylamine, or NDEA, was detected in the active pharmaceutical ingredient (API) irbesartan. The recalls were included in the November 28, 2018, US Food and Drug Administration (FDA) Enforcement Report.

On October 29, 2018, ScieGen Pharmaceuticals Inc. issued a voluntary recall for the following tablets it manufactured:

  • 75-mg irbesartan tablets, manufactured for Westminster Pharmaceuticals, in 30-count bottles (NDC 69367-119-01) from lot B160002A (Exp. 9/19) and 90-count bottles (NDC 69367-119-03) from lot B160002B (Exp. 9/19);
  • 150-mg irbesartan tablets, manufactured for Westminster Pharmaceuticals, in 30-count bottles (NDC 69367-120-01) from lots B161005A (Exp. 9/19) and C161002A (Exp. 2/20), and 90-count bottles (NDC 69367-120-03) from lots B161005B (Exp. 9/19) and C161002B (Exp. 2/20);
  • 300-mg irbesartan tablets, manufactured for Westminster Pharmaceuticals, in 30-count bottles (NDC 69367-121-01) from lots B162008A (Exp. 9/19) and C162002A (Exp. 2/20), and 90-count bottles (NDC 69367-121-03) from lots B162008B (Exp. 9/19) and C162002B (Exp. 2/20);
  • 75-mg irbesartan tablets, marketed by Golden State Medical Supply Inc., in 90-count bottles (NDC 60429-640-90) from lots B160003 (Exp. 9/19) and B160004 (Exp. 9/19);
  • 150-mg irbesartan tablets, marketed by Golden State Medical Supply Inc., in 30-count bottles (NDC 60429-641-30) from lots GS019526 (Exp. 11/19), GS020252 (Exp. 11/19), and GS020958 (Exp. 11/19), and 90-count bottles (NDC 60429-641-90) from lots B161003 (Exp. 9/19), B161004 (Exp. 9/19), B161006 (Exp. 9/19), B161007 (Exp. 9/19), B161008 (Exp. 11/19), B161009 (Exp. 11/19), B161010 (Exp. 11/19), C161001 (Exp. 2/20), and C161003 (Exp. 5/20); and
  • 300-mg irbesartan tablets, marketed by Golden State Medical Supply Inc., in 30-count bottles (NDC 60429-642-30) from lots GS019036 (Exp. 9/19), GS019073 (Exp. 9/19), GS021472 (Exp. 11/19), GS021530 (Exp. 11/19), and GS022234 (Exp. 2/20), and 90-count bottles (NDC 60429-642-90) from lots B162009 (Exp. 9/19), B162010 (Exp. 9/19), B162011 (Exp. 9/19), B162012 (Exp. 11/19), B162013 (Exp. 11/19), B162014 (Exp. 11/19), B162015 (Exp. 11/19), and C162001 (Exp. 2/20).

On November 2, 2018, Golden State Medical Supply Inc. seconded the ScieGen Pharmaceuticals recall with a voluntary recall of its own on the products it marketed (listed above).

All the recalled irbesartan tablets were distributed throughout the United States. On November 20, 2018, the FDA designated the recalls 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. Over the last 6 months, hypertension drugs containing valsartan as well as losartan potassium and hydrochlorothiazide have also been recalled due to NDEA concerns.

Jolynn Tumolo


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