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Torrent expands recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets

Trace Amounts of N-Nitrosodimethylamine impurity were found in an active pharmaceutical ingredient

Photo
Photo source: FDA
Torrent Pharmaceuticals Limited is expanding an earlier recall to include all lots of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan tablets.

Trace amounts of N-Nitrosodimethylamine impurity were found in an active pharmaceutical ingredient (API).

NDMA is classified as a probable human carcinogen (a substance that could cause cancer).

The company has not received any reports of adverse events to date related to this recall.

Valsartan is used to control high blood pressure and for the treatment of heart failure. In combination with amlodipine or amlodipine plus hydrochlorothiazide, it is used to control high blood pressure.

The following products, packaged in bottles and distributed nationwide, are being recalled:

NDCProduct Descrip.Lot/BatchExpiration Date

NDC

13668

-325

-30

Amlodipine, Valsartan

and Hydrochlorothiazide

Tablets, USP 10mg/320mg/25mg

30 Tablets

BBX2D025Nov-2019

NDC

13668

-325-

30

Amlodipine, Valsartan

and Hydrochlorothiazide

Tablets, USP 10mg/320mg/25mg

30 Tablets

BBX2D026Nov-2019

NDC

13668-

325-

30

Amlodipine, Valsartan and

Hydrochlorothiazide Tablets

USP 10mg/320mg/25mg

30 Tablets

BBX2E001Jan-2020

NDC

13668

-325-

30

Amlodipine, Valsartan and

Hydrochlorothiazide Tablets

USP 10mg/320mg/25mg, 30 Tablets

 

BBX2E002Jan-2020

NDC

13668

-325

-30

Amlodipine, Valsartan and

Hydrochlorothiazide Tablets

USP 10mg/320mg/25mg

30 Tablets

BBX2E003Jan-2020

NDC

13668

-325

-30

Amlodipine, Valsartan and

Hydrochlorothiazide Tablets

USP 10mg/320mg/25mg

30 Tablets

BBX2E004Jan-2020

NDC

13668

-325

-30

Amlodipine, Valsartan and

Hydrochlorothiazide Tablets

USP 10mg/320mg/25mg

30 Tablets

BBX2E005Jan-2020

NDC

13668

-328-

30

Amlodipine, Valsartan and

Hydrochlorothiazide Tablets

USP 10mg/160mg/25mg

30 Tablets

BBX9D004Nov-2019

NDC

13668-

328-

30

Amlodipine, Valsartan and

Hydrochlorothiazide Tablets

USP 10mg/160mg/25mg

30 Tablets

BBX9E001Jan-2020

NDC

13668

-326-

30

Amlodipine, Valsartan and

Hydrochlorothiazide Tablets

USP 5mg/160mg/12.5mg

30 Tablets

BBY1E001Dec-2019

NDC

13668

-326-

30

Amlodipine, Valsartan and

Hydrochlorothiazide Tablets

USP 5mg/160mg/12.5mg

30 Tablets

BBY1E003Mar-2020

NDC

13668

-327

-30

Amlodipine, Valsartan and

Hydrochlorothiazide Tablets

USP 10mg/160mg/12.5mg

30 Tablets

BBY2E001Mar-2020

NDC

13668

-329

-30

Amlodipine, Valsartan and

Hydrochlorothiazide Tablets

USP 5mg/160mg/25mg

30 Tablets

BBY4D004Nov-2019

NDC

13668-

329-

30

Amlodipine, Valsartan and

Hydrochlorothiazide Tablets

USP 5mg/160mg/25mg

30 Tablets

BBY4E001Jan-2020

NDC

13668-

329-

30

Amlodipine, Valsartan and

Hydrochlorothiazide Tablets

USP 5mg/160mg/25mg

30 Tablets

BBY4E001Jan-2020

NDC

13668-

325-

30

Amlodipine, Valsartan and

Hydrochlorothiazide Tablets

USP 10mg/320mg/25mg

30 Tablets

BBX2D003Mar-2019

NDC

13668-

325-

30

Amlodipine, Valsartan and

Hydrochlorothiazide Tablets

USP 10mg/320mg/25mg

30 Tablets

BBX2D004Mar-2019

NDC

13668

-325-

30

Amlodipine, Valsartan and

Hydrochlorothiazide Tablets

USP 10mg/320mg/25mg

30 Tablets

BBX2D005Mar-2019

NDC

13668-

325-

30

Amlodipine, Valsartan and

Hydrochlorothiazide Tablets

USP 10mg/320mg/25mg

30 Tablets

BBX2D006Mar-2019

NDC

13668-

325-

30

 

Amlodipine, Valsartan and

Hydrochlorothiazide Tablets

USP 10mg/320mg/25mg

30 Tablets

BBX2D007Mar-2019

NDC

13668-

325-

30

Amlodipine, Valsartan and

Hydrochlorothiazide Tablets

USP 10mg/320mg/25mg

30 Tablets

BBX2D008Mar-2019

NDC

13668-

325-

30

Amlodipine, Valsartan and

Hydrochlorothiazide Tablets

USP 10mg/320mg/25mg

30 Tablets

BBX2D015Oct 2019

NDC

13668-

325

-30

Amlodipine, Valsartan and

Hydrochlorothiazide Tablets

USP 10mg/320mg/25mg

30 Tablets

BBX2D016Oct 2019

NDC

13668-

325-

30

Amlodipine, Valsartan and

Hydrochlorothiazide Tablets

USP 10mg/320mg/25mg

30 Tablets

BBX2D017Oct 2019

NDC

13668

-325-

30

Amlodipine, Valsartan and

Hydrochlorothiazide Tablets

USP 10mg/320mg/25mg

30 Tablets

BBX2D018Oct 2019

NDC

13668

-325-

30

Amlodipine, Valsartan and

Hydrochlorothiazide Tablets

USP 10mg/320mg/25mg

30 Tablets

BBX2D019Oct 2019

NDC

13668-

325-

30

Amlodipine, Valsartan and

Hydrochlorothiazide Tablets

USP 10mg/320mg/25mg

30 Tablets

BBX2D020Oct 2019

NDC

13668-

325-

30

Amlodipine, Valsartan and

Hydrochlorothiazide Tablets

USP 10mg/320mg/25mg

30 Tablets

BBX2D021Oct 2019

NDC

13668-

325-

30

Amlodipine, Valsartan and

Hydrochlorothiazide Tablets

USP 10mg/320mg/25mg

30 Tablets

BBX2D022Oct 2019

NDC

13668

-325-

30

Amlodipine, Valsartan and

Hydrochlorothiazide Tablets

USP 10mg/320mg/25mg

30 Tablets

BBX2D023Oct 2019

NDC

13668

-325-

30

Amlodipine, Valsartan and

Hydrochlorothiazide Tablets

USP 10mg/320mg/25mg

30 Tablets

BBX2D024Nov 2019

NDC

13668-

328-

30

Amlodipine, Valsartan and

Hydrochlorothiazide Tablets

USP 10mg/160mg/25mg

30 Tablets

BBX9D001Feb 2019

NDC

13668-

326-

30

Amlodipine, Valsartan and

Hydrochlorothiazide Tablets

USP 5mg/160mg/12.5mg

30 Tablets

BBY1C002Sep 2018

NDC

13668

-326-

30

Amlodipine, Valsartan and

Hydrochlorothiazide Tablets

USP 5mg/160mg/12.5mg

30 Tablets

BBY1E002Mar-2020

13668

-327-

30

Amlodipine, Valsartan and

Hydrochlorothiazide Tablets

USP 10mg/160mg/12.5mg

, 30 Tablets

BBY2D001Feb 2019

13668-

327-3

0

Amlodipine, Valsartan and

Hydrochlorothiazide Tablets

USP 10mg/160mg/12.5mg

30 Tablets

BBY2D002Nov 2019

NDC

13668-

207-

30

Amlodipine and Valsartan

Tablets 5 mg/160 mg, USP, 3

0 Tablets

BV53D004Oct 2019

NDC

13668

-206-

30

Amlodipine and Valsartan

Tablets 10 mg/160 mg, USP

30 Tablets

BV65D002Oct 2019

NDC

13668

-204

-30

Amlodipine and Valsartan

Tablets 10 mg/320 mg, USP

30 Tablets

BV77D013Oct 2019

NDC

13668

-205

-30

Amlodipine and Valsartan

Tablets 5 mg/320 mg, USP

30 Tablets

BV84D010Oct 2019

NDC

13668-

205-

30

Amlodipine and Valsartan

Tablets 5 mg/320 mg, USP

30 Tablets

BV84E001Dec 2019

NDC

13668

-325

-30

Amlodipine, Valsartan and

Hydrochlorothiazide Tablets

USP 10mg/320mg/25mg

30 Tablets

BBX2D001Dec 2018

NDC

13668

325-

30

Amlodipine, Valsartan and

Hydrochlorothiazide Tablets

USP 10mg/320mg/25mg

30 Tablets

BBX2D002Dec 2018

NDC

13668

-325

-30

Amlodipine, Valsartan and

Hydrochlorothiazide Tablets

USP 10mg/320mg/25mg

30 Tablets

BBX2D009Mar 2019

NDC

13668

-325

-30

Amlodipine, Valsartan and

Hydrochlorothiazide Tablets

USP 10mg/320mg/25mg

30 Tablets

BBX2D010Apr 2019

NDC

13668

-325-

30

Amlodipine, Valsartan and

Hydrochlorothiazide Tablets

USP 10mg/320mg/25mg

30 Tablets

BBX2D011Apr 2019

NDC

13668-

325-

30

Amlodipine, Valsartan and

Hydrochlorothiazide Tablets

USP 10mg/320mg/25mg

30 Tablets

BBX2D012May 2019

NDC

13668

-325

-30

Amlodipine, Valsartan and

Hydrochlorothiazide Tablets

USP 10mg/320mg/25mg

30 Tablets

BBX2D013May 2019

NDC

13668

-325

-30

Amlodipine, Valsartan and

Hydrochlorothiazide Tablets

USP 10mg/320mg/25mg

30 Tablets

BBX2D014Aug 2019

NDC

13668

-328-

30

Amlodipine, Valsartan and

Hydrochlorothiazide Tablets

USP 10mg/160mg/25mg

30 Tablets

BBX9D002Mar 2019

NDC

13668

-328-

30

Amlodipine, Valsartan and

Hydrochlorothiazide Tablets

USP 10mg/160mg/25mg

30 Tablets

BBX9D003Jul 2019

NDC

13668

-326-

30

Amlodipine, Valsartan and

Hydrochlorothiazide Tablets

USP 5mg/160mg/12.5mg

30 Tablets

BBY1D001May 2019

NDC

13668

-329-

30

Amlodipine, Valsartan and

Hydrochlorothiazide Tablets

USP 5mg/160mg/25mg

30 Tablets

BBY4D001Apr 2019

NDC

13668

-329-

30

Amlodipine, Valsartan and

Hydrochlorothiazide Tablets

USP 5mg/160mg/25mg

30 Tablets

BBY4D002Apr 2019

NDC

13668

-329

-30

Amlodipine, Valsartan and

Hydrochlorothiazide Tablets

USP 5mg/160mg/25mg

30 Tablets

BBY4D003Jun 2019

NDC

13668-

068-

90

Valsartan Tablets, USP

80 mg, 90 Tablets

BV46C007Sept 2018

NDC

13668-

068-

90

Valsartan Tablets, USP

80 mg, 90 Tablets

BV46C008Oct 2018

NDC

1366

-068

-90

Valsartan Tablets, USP

80 mg, 90 Tablets

BV46C009Oct 2018

NDC

13668

-068

-90

Valsartan Tablets, USP

80 mg, 90 Tablets

BV46C010Oct 2018

NDC

13668

-068

-90

Valsartan Tablets, USP

80 mg, 90 Tablets

BV46C011Nov 2018

NDC

13668

-068-

90

Valsartan Tablets, USP

80 mg, 90 Tablets

BV46C012Nov 2018

NDC

13668

-069

-90

Valsartan Tablets, USP

160 mg, 90 Tablets

BV47C005Sep 2018

NDC

13668

-069

-90

Valsartan Tablets, USP

160 mg, 90 Tablets

BV47C006Sept 2018

NDC

13668

-069

-90

Valsartan Tablets, USP

160 mg, 90 Tablets

BV47D001Dec 2018

NDC

13668

-070

-90

Valsartan Tablets, USP

, 320 mg, 90 Tablets

BV48D001Dec 2018

NDC

13668

-070

-90

Valsartan Tablets, USP

320 mg, 90 Tablets

BV48D002Dec 2018

NDC

13668

-207

-30

Amlodipine and Valsartan

Tablets 5 mg/160 mg

USP, 30 Tablets

BV53C006Nov 2018

NDC

13668

-207

-30

Amlodipine and Valsaran

Tablets 5 mg/160 mg

USP, 30 Tablets

BV53D001Feb 2019

NDC

13668

-207-

30

Amlodipine and Valsartan

Tablets 5 mg/160 mg

USP, 30 Tablets

BV53D002Feb 2019

NDC

13668-

207-

30

Amlodipine and Valsartan

Tablets 5 mg/160 mg

USP, 30 Tablets

BV53D003Sep 2019

NDC

13668

-206

-30

Amlodipine and Valsartan

Tablets 10 mg/160 mg

USP, 30 Tablets

BV65C002Sep 2018

NDC

13668

-206-

30

Amlodipine and Valsartan

Tablets 10 mg/160 mg

USP, 30 Tablets

BV65C003Oct 2018

NDC

13668

-206-

30

Amlodipine and Valsartan

Tablets 10 mg/160 mg

USP, 30 Tablets

BV65C004Nov 2018

NDC

13668-

206-

30

Amlodipine and Valsartan

Tablets 10 mg/160 mg

USP, 30 Tablets

BV65D001Aug 2019

NDC

13668-

204-

30

Amlodipine and Valsartan

Tablets 10 mg/320 mg

USP, 30 Tablets

BV77C011Oct 2018

NDC

13668-

204

-30

Amlodipine and Valsartan

Tablets 10 mg/320 mg

USP, 30 Tablets

BV77D001Feb 2019

NDC

13668

-204-

30

Amlodipine and Valsartan

Tablets 10 mg/320 mg

USP, 30 Tablets

BV77D002Feb 2019

NDC

13668-

204

-30

Amlodipine and Valsartan

Tablets 10 mg/320 mg

USP, 30 Tablets

BV77D003Feb 2019

NDC

13668-

204-

30

Amlodipine and Valsartan

Tablets 10 mg/320 mg

USP, 30 Tablets

BV77D004Feb 2019

NDC

13668-

204-

30

Amlodipine and

Valsartan Tablets

10 mg/320 mg

USP, 30 Tablets

BV77D005Feb 2019

NDC

13668

-204-

30

Amlodipine and

Valsartan Tablets

10 mg/320 mg

USP, 30 Tablets

BV77D006Feb 2019

NDC

13668-

204-

30

Amlodipine and

Valsartan Tablets

10 mg/320 mg

USP, 30 Tablets

BV77D007Feb 2019

NDC

13668-

204-

30

Amlodipine and

Valsartan Tablets

10 mg/320 mg

USP, 30 Tablets

BV77D008May 2019

NDC

13668

-204-

30

Amlodipine and

Valsartan Tablets

10 mg/320 mg

USP, 30 Tablets

BV77D009Aug 2019

NDC

13668-

204-

30

Amlodipine and

Valsartan Tablets

10 mg/320 mg

USP, 30 Tablets

BV77D010Sep 2019

NDC

13668-

204-

30

Amlodipine and

Valsartan Tablets

10 mg/320 mg

USP, 30 Tablets

BV77D011Sep 2019

NDC

13668-

204-

30

Amlodipine and

Valsartan Tablets

10 mg/320 mg

USP, 30 Tablets

BV77D012Sep 2019

NDC

13668-

205

-30

Amlodipine and

Valsartan Tablets

5 mg/320 mg

USP, 30 Tablets

BV84C011Oct 2018

NDC

13668

-205

-30

Amlodipine and

Valsartan Tablets

5 mg/320 mg

USP, 30 Tablets

BV84D001Jan 2019

NDC

13668

-205

-30

Amlodipine and

Valsartan Tablets

5 mg/320 mg

USP, 30 Tablets

BV84D002Jan 2019

NDC

13668-

205-

30

Amlodipine and

Valsartan Tablets

5 mg/320 mg

USP, 30 Tablets

BV84D005Feb 2019

NDC

13668-205-30

Amlodipine and

Valsartan Tablets

5 mg/320 mg

USP, 30 Tablets

BV84D006Feb 2019

NDC

13668-

205

-30

 

Amlodipine and

Valsartan Tablets

5 mg/320 mg

USP, 30 Tablets

BV84D007Feb 2019

NDC

13668

-205-

30

Amlodipine and

Valsartan Tablets

5 mg/320 mg

USP, 30 Tablets

BV84D008May 2019

NDC

13668

-205

-30

Amlodipine and

Valsartan Tablets

5 mg/320 mg

USP, 30 Tablets

BV84D009May 2019

NDC

13668-

204

-30

 

Amlodipine and

Valsartan Tablets

10 mg/320 mg

USP, 30 Tablets

BV77C009Aug 2018

NDC

13668

-204

-30

Amlodipine and

Valsartan Tablets

10 mg/320 mg

USP, 30 Tablets

BV77C010Aug 2018

NDC

13668

-207

-30

Amlodipine and

Valsartan Tablets

5 mg/160 mg

USP, 30 Tablets

BV53C004Aug 2018

NDC

13668

-207

-30

Amlodipine and

Valsartan Tablets

5 mg/320 mg

USP, 30 Tablets

BV53C005Aug 2018

NDC

13668

-205

-30

Amlodipine and

Valsartan Tablets

5 mg/320 mg

USP, 30 Tablets

BV84C006Aug 2018

NDC

13668

-205

-30

Amlodipine and

Valsartan Tablets

5 mg/320 mg

USP, 30 Tablets

BV84C007Aug 2018

NDC

13668

-205

-30

Amlodipine and

Valsartan Tablets

5 mg/320 mg

USP, 30 Tablets

BV84C008Aug 2018

NDC

13668-205-30

Amlodipine

and Valsartan

Tablets

5 mg/320 mg

USP, 30 Tablets

BV84C009Aug 2018

NDC

13668-

325

-30

Amlodipine

Valsartan and

Hydrochlorothiazide

Tablets

USP

10mg/

320mg/

25mg

30 Tablets

BBX2C007Aug 2018

NDC

13668

-069

-90

Valsartan

Tablets USP

160 mg

90 Tablets

BV47C003Aug 2018

NDC

13668

-069-

90

Valsartan

Tablets USP

160 mg

90 Tablets

BV47C004Aug 2018

NDC

13668

-068-

90

Valsartan

Tablets USP

80 mg

90 Tablets

BV46C003Aug 2018

NDC

13668

-068-

90

Valsartan

Tablets USP

, 80 mg

90 Tablets

BV46C006Aug 2018

What to do

The company is arranging for return of all recalled products to Qualanex LLC, with instructions for returning recalled products are given in the recall letter.

Consumers with questions regarding this recall or reporting an adverse event may contact Torrent at (800) 912-9561 from 8:00 am – 5:00 pm, or by email at Medinfo.Torrent@apcerls.com.

For general questions regarding the return of the recalled products, contact Qualanex at (800) 505-9291 from 8 am -5:30 pm (ET).

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