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:
| NDC | Product Description | Lot/Batch | Expiration Date |
|---|---|---|---|
| NDC 13668-325-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 Tablets | BBX2D025 | Nov-2019 |
| NDC 13668-325-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 Tablets | BBX2D026 | Nov-2019 |
| NDC 13668-325-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 Tablets | BBX2E001 | Jan-2020 |
| NDC 13668-325-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 Tablets | BBX2E002 | Jan-2020 |
| NDC 13668-325-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 Tablets | BBX2E003 | Jan-2020 |
| NDC 13668-325-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 Tablets | BBX2E004 | Jan-2020 |
| NDC 13668-325-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 Tablets | BBX2E005 | Jan-2020 |
| NDC 13668-328-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/160mg/25mg, 30 Tablets | BBX9D004 | Nov-2019 |
| NDC 13668-328-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/160mg/25mg, 30 Tablets | BBX9E001 | Jan-2020 |
| NDC 13668-326-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 5mg/160mg/12.5mg, 30 Tablets | BBY1E001 | Dec-2019 |
| NDC 13668-326-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 5mg/160mg/12.5mg, 30 Tablets | BBY1E003 | Mar-2020 |
| NDC 13668-327-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/160mg/12.5mg, 30 Tablets | BBY2E001 | Mar-2020 |
| NDC 13668-329-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 5mg/160mg/25mg, 30 Tablets | BBY4D004 | Nov-2019 |
| NDC 13668-329-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 5mg/160mg/25mg, 30 Tablets | BBY4E001 | Jan-2020 |
| NDC 13668-329-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 5mg/160mg/25mg, 30 Tablets | BBY4E001 | Jan-2020 |
| NDC 13668-325-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 Tablets | BBX2D003 | Mar-2019 |
| NDC 13668-325-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 Tablets | BBX2D004 | Mar-2019 |
| NDC 13668-325-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 Tablets | BBX2D005 | Mar-2019 |
| NDC 13668-325-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 Tablets | BBX2D006 | Mar-2019 |
| NDC 13668-325-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 Tablets | BBX2D007 | Mar-2019 |
| NDC 13668-325-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 Tablets | BBX2D008 | Mar-2019 |
| NDC 13668-325-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 Tablets | BBX2D015 | Oct 2019 |
| NDC 13668-325-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 Tablets | BBX2D016 | Oct 2019 |
| NDC 13668-325-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 Tablets | BBX2D017 | Oct 2019 |
| NDC 13668-325-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 Tablets | BBX2D018 | Oct 2019 |
| NDC 13668-325-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 Tablets | BBX2D019 | Oct 2019 |
| NDC 13668-325-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 Tablets | BBX2D020 | Oct 2019 |
| NDC 13668-325-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 Tablets | BBX2D021 | Oct 2019 |
| NDC 13668-325-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 Tablets | BBX2D022 | Oct 2019 |
| NDC 13668-325-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 Tablets | BBX2D023 | Oct 2019 |
| NDC 13668-325-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 Tablets | BBX2D024 | Nov 2019 |
| NDC 13668-328-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/160mg/25mg, 30 Tablets | BBX9D001 | Feb 2019 |
| NDC 13668-326-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 5mg/160mg/12.5mg, 30 Tablets | BBY1C002 | Sep 2018 |
| NDC 13668-326-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 5mg/160mg/12.5mg, 30 Tablets | BBY1E002 | Mar-2020 |
| 13668-327-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/160mg/12.5mg, 30 Tablets | BBY2D001 | Feb 2019 |
| 13668-327-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/160mg/12.5mg, 30 Tablets | BBY2D002 | Nov 2019 |
| NDC 13668-207-30 | Amlodipine and Valsartan Tablets 5 mg/160 mg, USP, 30 Tablets | BV53D004 | Oct 2019 |
| NDC 13668-206-30 | Amlodipine and Valsartan Tablets 10 mg/160 mg, USP, 30 Tablets | BV65D002 | Oct 2019 |
| NDC 13668-204-30 | Amlodipine and Valsartan Tablets 10 mg/320 mg, USP, 30 Tablets | BV77D013 | Oct 2019 |
| NDC 13668-205-30 | Amlodipine and Valsartan Tablets 5 mg/320 mg, USP, 30 Tablets | BV84D010 | Oct 2019 |
| NDC 13668-205-30 | Amlodipine and Valsartan Tablets 5 mg/320 mg, USP, 30 Tablets | BV84E001 | Dec 2019 |
| NDC 13668-325-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 Tablets | BBX2D001 | Dec 2018 |
| NDC 13668-325-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 Tablets | BBX2D002 | Dec 2018 |
| NDC 13668-325-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 Tablets | BBX2D009 | Mar 2019 |
| NDC 13668-325-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 Tablets | BBX2D010 | Apr 2019 |
| NDC 13668-325-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 Tablets | BBX2D011 | Apr 2019 |
| NDC 13668-325-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 Tablets | BBX2D012 | May 2019 |
| NDC 13668-325-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 Tablets | BBX2D013 | May 2019 |
| NDC 13668-325-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 Tablets | BBX2D014 | Aug 2019 |
| NDC 13668-328-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/160mg/25mg, 30 Tablets | BBX9D002 | Mar 2019 |
| NDC 13668-328-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/160mg/25mg, 30 Tablets | BBX9D003 | Jul 2019 |
| NDC 13668-326-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 5mg/160mg/12.5mg, 30 Tablets | BBY1D001 | May 2019 |
| NDC 13668-329-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 5mg/160mg/25mg, 30 Tablets | BBY4D001 | Apr 2019 |
| NDC 13668-329-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 5mg/160mg/25mg, 30 Tablets | BBY4D002 | Apr 2019 |
| NDC 13668-329-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 5mg/160mg/25mg, 30 Tablets | BBY4D003 | Jun 2019 |
| NDC 13668-068-90 | Valsartan Tablets, USP, 80 mg, 90 Tablets | BV46C007 | Sept 2018 |
| NDC 13668-068-90 | Valsartan Tablets, USP, 80 mg, 90 Tablets | BV46C008 | Oct 2018 |
| NDC 13668-068-90 | Valsartan Tablets, USP, 80 mg, 90 Tablets | BV46C009 | Oct 2018 |
| NDC 13668-068-90 | Valsartan Tablets, USP, 80 mg, 90 Tablets | BV46C010 | Oct 2018 |
| NDC 13668-068-90 | Valsartan Tablets, USP, 80 mg, 90 Tablets | BV46C011 | Nov 2018 |
| NDC 13668-068-90 | Valsartan Tablets, USP, 80 mg, 90 Tablets | BV46C012 | Nov 2018 |
| NDC 13668-069-90 | Valsartan Tablets, USP,160 mg, 90 Tablets | BV47C005 | Sep 2018 |
| NDC 13668-069-90 | Valsartan Tablets, USP, 160 mg, 90 Tablets | BV47C006 | Sept 2018 |
| NDC 13668-069-90 | Valsartan Tablets, USP, 160 mg, 90 Tablets | BV47D001 | Dec 2018 |
| NDC 13668-070-90 | Valsartan Tablets, USP, 320 mg, 90 Tablets | BV48D001 | Dec 2018 |
| NDC 13668-070-90 | Valsartan Tablets, USP, 320 mg, 90 Tablets | BV48D002 | Dec 2018 |
| NDC 13668-207-30 | Amlodipine and Valsartan Tablets 5 mg/160 mg, USP, 30 Tablets | BV53C006 | Nov 2018 |
| NDC 13668-207-30 | Amlodipine and Valsartan Tablets 5 mg/160 mg, USP, 30 Tablets | BV53D001 | Feb 2019 |
| NDC 13668-207-30 | Amlodipine and Valsartan Tablets 5 mg/160 mg, USP, 30 Tablets | BV53D002 | Feb 2019 |
| NDC 13668-207-30 | Amlodipine and Valsartan Tablets 5 mg/160 mg, USP, 30 Tablets | BV53D003 | Sep 2019 |
| NDC 13668-206-30 | Amlodipine and Valsartan Tablets 10 mg/160 mg, USP, 30 Tablets | BV65C002 | Sep 2018 |
| NDC 13668-206-30 | Amlodipine and Valsartan Tablets 10 mg/160 mg, USP, 30 Tablets | BV65C003 | Oct 2018 |
| NDC 13668-206-30 | Amlodipine and Valsartan Tablets 10 mg/160 mg, USP, 30 Tablets | BV65C004 | Nov 2018 |
| NDC 13668-206-30 | Amlodipine and Valsartan Tablets 10 mg/160 mg, USP, 30 Tablets | BV65D001 | Aug 2019 |
| NDC 13668-204-30 | Amlodipine and Valsartan Tablets 10 mg/320 mg, USP, 30 Tablets | BV77C011 | Oct 2018 |
| NDC 13668-204-30 | Amlodipine and Valsartan Tablets 10 mg/320 mg, USP, 30 Tablets | BV77D001 | Feb 2019 |
| NDC 13668-204-30 | Amlodipine and Valsartan Tablets 10 mg/320 mg, USP, 30 Tablets | BV77D002 | Feb 2019 |
| NDC 13668-204-30 | Amlodipine and Valsartan Tablets 10 mg/320 mg, USP, 30 Tablets | BV77D003 | Feb 2019 |
| NDC 13668-204-30 | Amlodipine and Valsartan Tablets 10 mg/320 mg, USP, 30 Tablets | BV77D004 | Feb 2019 |
| NDC 13668-204-30 | Amlodipine and Valsartan Tablets 10 mg/320 mg, USP, 30 Tablets | BV77D005 | Feb 2019 |
| NDC 13668-204-30 | Amlodipine and Valsartan Tablets 10 mg/320 mg, USP, 30 Tablets | BV77D006 | Feb 2019 |
| NDC 13668-204-30 | Amlodipine and Valsartan Tablets 10 mg/320 mg, USP, 30 Tablets | BV77D007 | Feb 2019 |
| NDC 13668-204-30 | Amlodipine and Valsartan Tablets 10 mg/320 mg, USP, 30 Tablets | BV77D008 | May 2019 |
| NDC 13668-204-30 | Amlodipine and Valsartan Tablets 10 mg/320 mg, USP, 30 Tablets | BV77D009 | Aug 2019 |
| NDC 13668-204-30 | Amlodipine and Valsartan Tablets 10 mg/320 mg, USP, 30 Tablets | BV77D010 | Sep 2019 |
| NDC 13668-204-30 | Amlodipine and Valsartan Tablets 10 mg/320 mg, USP, 30 Tablets | BV77D011 | Sep 2019 |
| NDC 13668-204-30 | Amlodipine and Valsartan Tablets 10 mg/320 mg, USP, 30 Tablets | BV77D012 | Sep 2019 |
| NDC 13668-205-30 | Amlodipine and Valsartan Tablets 5 mg/320 mg, USP, 30 Tablets | BV84C011 | Oct 2018 |
| NDC 13668-205-30 | Amlodipine and Valsartan Tablets 5 mg/320 mg, USP, 30 Tablets | BV84D001 | Jan 2019 |
| NDC 13668-205-30 | Amlodipine and Valsartan Tablets 5 mg/320 mg, USP, 30 Tablets | BV84D002 | Jan 2019 |
| NDC 13668-205-30 | Amlodipine and Valsartan Tablets 5 mg/320 mg, USP, 30 Tablets | BV84D005 | Feb 2019 |
| NDC 13668-205-30 | Amlodipine and Valsartan Tablets 5 mg/320 mg, USP, 30 Tablets | BV84D006 | Feb 2019 |
| NDC 13668-205-30 | Amlodipine and Valsartan Tablets 5 mg/320 mg, USP, 30 Tablets | BV84D007 | Feb 2019 |
| NDC 13668-205-30 | Amlodipine and Valsartan Tablets 5 mg/320 mg, USP, 30 Tablets | BV84D008 | May 2019 |
| NDC 13668-205-30 | Amlodipine and Valsartan Tablets 5 mg/320 mg, USP, 30 Tablets | BV84D009 | May 2019 |
| NDC 13668-204-30 | Amlodipine and Valsartan Tablets 10 mg/320 mg, USP, 30 Tablets | BV77C009 | Aug 2018 |
| NDC 13668-204-30 | Amlodipine and Valsartan Tablets 10 mg/320 mg, USP, 30 Tablets | BV77C010 | Aug 2018 |
| NDC 13668-207-30 | Amlodipine and Valsartan Tablets 5 mg/160 mg, USP, 30 Tablets | BV53C004 | Aug 2018 |
| NDC 13668-207-30 | Amlodipine and Valsartan Tablets 5 mg/320 mg, USP, 30 Tablets | BV53C005 | Aug 2018 |
| NDC 13668-205-30 | Amlodipine and Valsartan Tablets 5 mg/320 mg, USP, 30 Tablets | BV84C006 | Aug 2018 |
| NDC 13668-205-30 | Amlodipine and Valsartan Tablets 5 mg/320 mg, USP, 30 Tablets | BV84C007 | Aug 2018 |
| NDC 13668-205-30 | Amlodipine and Valsartan Tablets 5 mg/320 mg, USP, 30 Tablets | BV84C008 | Aug 2018 |
| NDC 13668-205-30 | Amlodipine and Valsartan Tablets 5 mg/320 mg, USP, 30 Tablets | BV84C009 | Aug 2018 |
| NDC 13668-325-30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 Tablets | BBX2C007 | Aug 2018 |
| NDC 13668-069-90 | Valsartan Tablets USP, 160 mg, 90 Tablets | BV47C003 | Aug 2018 |
| NDC 13668-069-90 | Valsartan Tablets USP, 160 mg, 90 Tablets | BV47C004 | Aug 2018 |
| NDC 13668-068-90 | Valsartan Tablets USP, 80 mg, 90 Tablets | BV46C003 | Aug 2018 |
| NDC 13668-068-90 | Valsartan Tablets USP, 80 mg, 90 Tablets | BV46C006 | Aug 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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