PhotoAurobindoPharma USA and Acetris Health are expanding an earlier recall of Valsartan and Amlodipine and Valsartan tablets, which are used to control high blood pressure and for the treatment of heart failure.

Trace amounts of an unexpected impurity, N-nitrosodiethylamine (NDEA) -- a probable human carcinogen – have been found in the product.

The following products, packaged in bottles, are being recalled:

NDCName and strengthCountLot numberExpiry

ACETRIS LOTS

52343-122-30Valsartan Tablets USP 40mg30470170038A19-Oct
52343-122-30Valsartan Tablets USP 40mg30470180010A20-Feb
52343-122-30Valsartan Tablets USP 40mg30470180012A20-Mar
52343-123-90Valsartan Tablets USP 80mg90471170019A19-Oct
52343-123-90Valsartan Tablets USP 80mg90471180006A20-Mar
52343-123-90Valsartan Tablets USP 80mg90471180007A20-Mar
52343-123-90Valsartan Tablets USP 80mg90471180016A20-May
52343-124-90Valsartan Tablets USP 160mg90472180005B20-Feb
52343-124-90Valsartan Tablets USP 160mg90472180011A20-Apr
52343-124-90Valsartan Tablets USP 160mg90472180012A20-Apr
52343-125-90Valsartan Tablets USP 320mg90473180007A20-Mar
52343-125-90Valsartan Tablets USP 320mg90473180008A20-Mar
52343-125-90Valsartan Tablets USP 320mg90473180011A20-Apr
52343-125-90Valsartan Tablets, USP 320mg90473180020B120-Jul
52343-125-90Valsartan Tablets, USP 320mg90473170019B19-Oct

AUROBINDO LOTS

65862-570-30Valsartan Tablets USP 40mg30470180008A20-Feb
65862-570-30Valsartan Tablets USP 40mg30470180014A20-Mar
65862-570-30Valsartan Tablets USP 40mg30470180016A20-Mar
65862-571-90Valsartan Tablets USP 80mg90471170015A19-Sep
65862-571-90Valsartan Tablets USP 80mg90471180004A20-Feb
65862-571-90Valsartan Tablets USP 80mg90471180005A20-Feb
65862-572-90Valsartan Tablets USP 160mg90472180001A20-Jan
65862-572-90Valsartan Tablets USP 160mg90472180002A20-Jan
65862-572-90Valsartan Tablets USP 160mg90472180003A20-Jan
65862-572-90Valsartan Tablets USP 160mg90472180004A20-Jan
65862-572-90Valsartan Tablets USP 160mg90472180007A20-Mar
65862-572-90Valsartan Tablets USP 160mg90472180008A20-Mar
65862-572-90Valsartan Tablets USP 160mg90472180009A20-Mar
65862-572-90Valsartan Tablets USP 160mg90472180010A20-Mar
65862-572-90Valsartan Tablets USP 160mg90472180013A20-Apr
65862-572-90Valsartan Tablets USP 160mg90472180014A20-Apr
65862-573-90Valsartan Tablets USP 320mg90473180004A20-Feb
65862-573-90Valsartan Tablets USP 320mg90473180005A20-Feb
65862-573-90Valsartan Tablets USP 320mg90473180006A20-Mar
65862-573-90Valsartan Tablets USP 320mg90473180017A20-May
65862-739-30Amlodipine and Valsartan Tablets USP10mg/160mg30VFSA17007-A19-Oct
65862-570-30Valsartan Tablets, USP 40mg30470180032A20-May
65862-573-90Valsartan Tablets, USP 320mg90473170019A19-Oct
65862-573-90Valsartan Tablets, USP 320mg90473180016A

The recalled products were distributed nationwide.

What to do

Patients should continue taking their medication, as the risk of harm to their health may be higher if the treatment is stopped immediately without any alternative treatment. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.

AurobindoPharma is notifying its customers by phone and in writing and arranging for return of all recalled products. Instructions for returning recalled products are given in the recall letter.

Consumers with medical questions regarding this recall may contact AurobindoPharma at (866) 850- 2876, Option 2 or by email at pvg@aurobindousa.com.


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