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AurobindoPharma USA recalls Amlodipine Valsartan and Valsartan tablets

The product contains trace amounts of NDEA impurity.

Photo
Photo source: FDA
AurobindoPharma 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:

NDCTypeCountLot numberExpiry

ACETRIS LOTS

52343-

122-

30

Valsartan

Tablets

USP 40mg

30

470170

038A

19-Oct

52343-

122-

30

Valsartan

Tablets

USP 40mg

30

470180

010A

20-Feb

52343-

122-

30

Valsartan

Tablets

USP 40mg

30

470180

012A

20-Mar

52343-

123-

90

Valsartan

Tablets

USP 80mg

90

471170

019A

19-Oct

52343-

123-

90

Valsartan

Tablets

USP 80mg

90

471180

006A

20-Mar

52343-

123-

90

Valsartan

Tablets

USP 80mg

90

471180

007A

20-Mar

52343-

123-

90

Valsartan

Tablets

USP 80mg

90

471180

016A

20-May

52343-

124-

90

Valsartan

Tablets

USP 160mg

90

472180

005B

20-Feb

52343-

124-

90

Valsartan

Tablets

USP 160mg

90

472180

011A

20-Apr

52343-

124-

90

Valsartan

Tablets

USP 160mg

90

472180

012A

20-Apr

52343-

125-

90

Valsartan

Tablets

USP 320mg

90

473180

007A

20-Mar

52343-

125-

90

Valsartan

Tablets

USP 320mg

90

473180

008A

20-Mar

52343-

125-

90

Valsartan

Tablets

USP 320mg

90

473180

011A

20-Apr

52343-

125-

90

Valsartan

Tablets

USP 320mg

90

473180

020B1

20-Jul

52343-

125-

90

Valsartan

Tablets

USP 320mg

90

473170

019B

19-Oct

AUROBINDO LOTS

65862-

570-

30

Valsartan

Tablets

USP 40mg

30

470180

008A

20-Feb

65862-

570-

30

Valsartan

Tablets

USP 40mg

30

470180

014A

20-Mar

65862-

570-

30

Valsartan

Tablets

USP 40mg

30

47018

0016A

20-Mar

65862-

571-

90

Valsartan

Tablets

USP 80mg

90

471170

015A

19-Sep

65862-

571-

90

Valsartan

Tablets

USP 80mg

90

471180

004A

20-Feb

65862-

571-

90

Valsartan

Tablets

USP 80mg

90

471180

005A

20-Feb

65862-

572-

90

Valsartan

Tablets

USP 160mg

90

472180

001A

20-Jan

65862-

572-

90

Valsartan

Tablets

USP 160mg

90

472180

002A

20-Jan

65862-

572-

90

Valsartan

Tablets

USP 160mg

90

472180

003A

20-Jan

65862-

572-

90

Valsartan

Tablets

USP 160mg

90

472180

004A

20-Jan

65862-

572-

90

Valsartan

Tablets

USP 160mg

90

472180

007A

20-Mar

65862-

572-

90

Valsartan

Tablets

USP 160mg

90

472180

008A

20-Mar

65862-

572-

90

Valsartan

Tablets

USP 160mg

90

472180

009A

20-Mar

65862-

572-

90

Valsartan

Tablets

USP 160mg

90

472180

010A

20-Mar

65862-

572-

90

Valsartan

Tablets

USP

160mg

90

47218

0013A

20-Apr

65862-

572-

90

Valsartan

Tablets

USP

160mg

90

472180

014A

20-Apr

65862-

573-

90

Valsartan

Tablets

USP

320mg

90

4731800

04A

20-Feb

65862-

573-

90

Valsartan

Tablets

USP

320mg

90

473180

005A

20-Feb

65862-

573-

90

Valsartan

Tablets

USP

320mg

90

473180

006A

20-Mar

65862-

573-

90

Valsartan

Tablets

USP

320mg

90

47318

0017A

20-May

65862-

739-

30

Amlodipine

and

Valsartan

Tablets

USP

10mg

/160mg

30

VFSA17

007-A

19-Oct

65862-

570-

30

Valsartan

Tablets

USP

40mg

30

470180

032A

20-May

65862-

573-

90

Valsartan

Tablets

USP

320mg

90

473170

019A

19-Oct

65862-

573-

90

Valsartan

Tablets

USP

320mg

90

473180

016A

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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