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Consumer News: AurobindoPharma USA recalls Amlodipine Valsartan and Valsartan tablets

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:

NDC Name and strength Count Lot number Expiry

ACETRIS LOTS

52343-122-30 Valsartan Tablets USP 40mg 30 470170038A 19-Oct
52343-122-30 Valsartan Tablets USP 40mg 30 470180010A 20-Feb
52343-122-30 Valsartan Tablets USP 40mg 30 470180012A 20-Mar
52343-123-90 Valsartan Tablets USP 80mg 90 471170019A 19-Oct
52343-123-90 Valsartan Tablets USP 80mg 90 471180006A 20-Mar
52343-123-90 Valsartan Tablets USP 80mg 90 471180007A 20-Mar
52343-123-90 Valsartan Tablets USP 80mg 90 471180016A 20-May
52343-124-90 Valsartan Tablets USP 160mg 90 472180005B 20-Feb
52343-124-90 Valsartan Tablets USP 160mg 90 472180011A 20-Apr
52343-124-90 Valsartan Tablets USP 160mg 90 472180012A 20-Apr
52343-125-90 Valsartan Tablets USP 320mg 90 473180007A 20-Mar
52343-125-90 Valsartan Tablets USP 320mg 90 473180008A 20-Mar
52343-125-90 Valsartan Tablets USP 320mg 90 473180011A 20-Apr
52343-125-90 Valsartan Tablets, USP 320mg 90 473180020B1 20-Jul
52343-125-90 Valsartan Tablets, USP 320mg 90 473170019B 19-Oct

AUROBINDO LOTS

65862-570-30 Valsartan Tablets USP 40mg 30 470180008A 20-Feb
65862-570-30 Valsartan Tablets USP 40mg 30 470180014A 20-Mar
65862-570-30 Valsartan Tablets USP 40mg 30 470180016A 20-Mar
65862-571-90 Valsartan Tablets USP 80mg 90 471170015A 19-Sep
65862-571-90 Valsartan Tablets USP 80mg 90 471180004A 20-Feb
65862-571-90 Valsartan Tablets USP 80mg 90 471180005A 20-Feb
65862-572-90 Valsartan Tablets USP 160mg 90 472180001A 20-Jan
65862-572-90 Valsartan Tablets USP 160mg 90 472180002A 20-Jan
65862-572-90 Valsartan Tablets USP 160mg 90 472180003A 20-Jan
65862-572-90 Valsartan Tablets USP 160mg 90 472180004A 20-Jan
65862-572-90 Valsartan Tablets USP 160mg 90 472180007A 20-Mar
65862-572-90 Valsartan Tablets USP 160mg 90 472180008A 20-Mar
65862-572-90 Valsartan Tablets USP 160mg 90 472180009A 20-Mar
65862-572-90 Valsartan Tablets USP 160mg 90 472180010A 20-Mar
65862-572-90 Valsartan Tablets USP 160mg 90 472180013A 20-Apr
65862-572-90 Valsartan Tablets USP 160mg 90 472180014A 20-Apr
65862-573-90 Valsartan Tablets USP 320mg 90 473180004A 20-Feb
65862-573-90 Valsartan Tablets USP 320mg 90 473180005A 20-Feb
65862-573-90 Valsartan Tablets USP 320mg 90 473180006A 20-Mar
65862-573-90 Valsartan Tablets USP 320mg 90 473180017A 20-May
65862-739-30 Amlodipine and Valsartan Tablets USP10mg/160mg 30 VFSA17007-A 19-Oct
65862-570-30 Valsartan Tablets, USP 40mg 30 470180032A 20-May
65862-573-90 Valsartan Tablets, USP 320mg 90 473170019A 19-Oct
65862-573-90 Valsartan Tablets, USP 320mg 90 473180016A

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 This email address is being protected from spambots. You need JavaScript enabled to view it..



Posted: 2019-03-13 13:50:35

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