Additional Hypertension Meds Pulled

More valsartan products are being recalled after trace amounts of a carcinogenic substance—N-nitrosodimethylamine (NDEA)—were found in an active pharmaceutical ingredient used to manufacture the products. The recalls were included in the March 27, 2019, US Food and Drug Administration (FDA) Enforcement Report.

Aurobindo Pharma USA is voluntarily recalling the following products, which were sent to major distribution chains throughout the United States: 

• valsartan tablets, 40 mg, 30-count bottles (NDC 65862-570-30), from lots 470180008A (Exp. 2/20); 470180014A and 470180016A (Exp. 3/20); and 470180032A (Exp.5/20); 
• valsartan tablets, 80 mg, 90-count bottles (NDC 65862-571-90), from lots 471170015A (Exp. 9/19); and 471180004A and 471180005A (Exp. 2/19); 
• valsartan tablets, 160 mg, 90-count bottles (NDC 65862-572-90), from lots 472180001A, 472180002A, 472180003A, and 472180004A (Exp. 1/20); 472180007A, 472180008A, 472180009A, and 472180010A (Exp. 3/20); and 472180013A and 472180014A (Exp. 4/20);
• valsartan tablets, 320 mg, 90-count bottles (NDC 65862-573-90), from lots 473180004A and 473180005A (Exp. 2/20); 473180006A (Exp. 3/20); 473180016A and 473180017A (Exp. 5/20); and 473170019A (Exp. 10/19); and 
• amlodipine and valsartan tablets, 10 mg/160 mg, 30-count bottles (NDC 65862-739-30), from lot VFSA17007-A (Exp. 10/19).

Rising Pharmaceuticals Inc. is voluntarily recalling the following products, which were sent to six major distributors who may have further distributed them throughout the United States:

• valsartan tablets, 40 mg, 30-tablet bottles (NDC 52343-122-30), manufactured by Aurolife Pharma and distributed by Acetris Health, from lots 470170038A (Exp. 10/31/19); 470180010A (Exp. 2/29/19); and 470180012A (Exp. 3/31/20);
• valsartan tablets, 80 mg, 90-tablet bottles (NDC 52343-123-90), manufactured by Aurolife Pharma and distributed by Acetris Health, from lots 471170019A (Exp. 10/31/19); 471180006A (Exp. 3/31/20); 471180007A (Exp. 3/31/20); and 471180016A (Exp. 5/31/20); 
• valsartan tablets, 160 mg, 90-tablet bottles (NDC 52343-124-90), manufactured by Aurolife Pharma and distributed by Acetris Health, from lots 472180005B (Exp. 2/29/20); 472180011A (Exp. 4/30/20); and 472180012A (Exp. 4/30/20);  
• valsartan tablets, 320 mg, 90-tablet bottles (NDC 52343-125-90), manufactured by Aurolife Pharma and distributed by Acetris Health, from lots 473180007A (Exp. 3/31/20); 473180008A (Exp. 3/31/20); 473180011A (Exp. 4/30/20); 473180020B1 (Exp. 7/31/20); and 473170019B (Exp. 10/31/19). 

American Health Packaging is voluntarily recalling the following products, which were distributed throughout the United States and in Puerto Rico:

•  valsartan tablets, 160 mg, 100-tablets (10 x 10) per unit dose blisters (individual dose NDC 60687-139-11, carton NDC 60687-139-01), from lot 179791 (Exp. 3/20).

On March 21, 2019, the FDA designated the recalls Class II. According to the classification, use of the recalled drugs may cause temporary or medically reversible adverse health consequences. While remote, a possibility of serious harm also exists.

Valsartan is a prescription angiotensin receptor blocker used to treat patients with high blood pressure and congestive heart failure.

—Jolynn Tumolo