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  4. UPDATED:ADDITIONAL LOTS ADDED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets
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COMPANY ANNOUNCEMENT

UPDATED:ADDITIONAL LOTS ADDED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

Read Announcement

UPDATED:ADDITIONAL LOTS ADDED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets

Summary

Company Announcement Date:
August 23, 2018
FDA Publish Date:
April 06, 2019
Product Type:
Drugs
Reason for Announcement:
Company Name:
Torrent Pharmaceuticals Limited
Brand Name:
Brand Name(s)
Torrent Pharmaceuticals Limited
Product Description:
Product Description
Valsartan/Amlodipine/HCTZ; Valsartan/Amlodipine; and Valsartan tablets

Company Announcement

Torrent Pharmaceuticals Limited is voluntarily recalling ALL LOTS within expiry of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.

To date, Torrent Pharmaceuticals Limited has not received any reports of adverse events 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. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication. Patients who are on valsartan should continue taking their medication, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment.

The products subject to recall are listed below and packaged in bottles. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.

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
 

Valsartan/Amlodipine/HCTZ. Valsartan/Amlodipine and Valsartan tablets were distributed Nationwide to Torrent's wholesale, distributor, repackager and retail customers. Torrent Pharmaceuticals Limited is notifying its distributors and customers by phone and in writing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts. Torrent is arranging for return of all recalled products to Qualanex. Instructions for returning recalled products are given in the recall letter.

Consumers with medical questions regarding this recall or to report an adverse event can contact Torrent Pharmaceuticals Limited at:

  • 1-800-912-9561 (live calls received 8:00 am – 5:00 pm Eastern Time, voicemail available 24 hours/day, 7 days/week).
  • Medinfo.Torrent@apcerls.com

Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Any general questions regarding the return of this product please contact Qualanex at 1-888-424-4340 or 1-800- 505-9291 (live calls received 8 am -5:30 pm Eastern Time).

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Photo of_ Amlodipine_Valsartan HCTZ Tablets
Photo of_ Amlodipine_Valsartan HCTZ Tablets
Photo of_ Amlodipine_Valsartan HCTZ Tablets
Photo of_ Amlodipine_Valsartan HCTZ Tablets
Photo of_ Amlodipine_Valsartan HCTZ Tablets
Label for:  Amlodipine, Valsartan, Hydrochlorothiazide 5 mg/160 mg/12.5 mg
Label for:  Amlodipine, Valsartan, Hydrochlorothiazide 10 mg/160 mg/12.5 mg
Label for_ Amlodipine, Valsartan, Hydrochlorothiazide 10 mg_160 mg_25 mg
Label for_ Amlodipine, Valsartan, Hydrochlorothiazide 5 mg_160 mg_25 mg

Label for:  Amlodipine, Valsartan, Hydrochlorothiazide 10 mg/320 mg/25 mg

Photo of_ Amlodipine_Valsartan Tablets
Photo of:  Amlodipine/Valsartan Tablets
Photo of:  Amlodipine/Valsartan Tablets
Photo of:  Amlodipine/Valsartan Tablets
Label for:  Amlodipine and Valsartan Tablets, USP 5 mg/160 mg
Label for:  Amlodipine and Valsartan Tablets, USP 5 mg/320 mg
Label for_Amlodipine and Valsartan Tablets, USP 10 mg_320 mg_16
Photo of_ Valsartan Tablets
Photo of_ Valsartan Tablets

Photo of:  Valsartan Tablets

Label for:  Valsartan Tablets, USP 80 mg

Label for:  Valsartan Tablets, USP 160 mg

Label for:  Valsartan Tablets, USP 320 mg

Consumers

Torrent Medical Information
Medinfo.Torrent@apcerls.com
1-800-912-9561
Qualanex
1-888-424-4340
1-800- 505-9291