Safety

Product Photos

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/160 mg

Label for:  Amlodipine and Valsartan Tablets, USP 10 mg/320 mg

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

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.

NDCProduct DescriptionLot/BatchExpiration Date
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D025Nov-2019
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D026Nov-2019
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2E001Jan-2020
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2E002Jan-2020
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2E003Jan-2020
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2E004Jan-2020
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2E005Jan-2020
NDC 13668-328-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/160mg/25mg, 30 TabletsBBX9D004Nov-2019
NDC 13668-328-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/160mg/25mg, 30 TabletsBBX9E001Jan-2020
NDC 13668-326-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 5mg/160mg/12.5mg, 30 TabletsBBY1E001Dec-2019
NDC 13668-326-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 5mg/160mg/12.5mg, 30 TabletsBBY1E003Mar-2020
NDC 13668-327-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/160mg/12.5mg, 30 TabletsBBY2E001Mar-2020
NDC 13668-329-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 5mg/160mg/25mg, 30 TabletsBBY4D004Nov-2019
NDC 13668-329-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 5mg/160mg/25mg, 30 TabletsBBY4E001Jan-2020
NDC 13668-329-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 5mg/160mg/25mg, 30 TabletsBBY4E001Jan-2020
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D003Mar-2019
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D004Mar-2019
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D005Mar-2019
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D006Mar-2019
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D007Mar-2019
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D008Mar-2019
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D015Oct 2019
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D016Oct 2019
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D017Oct 2019
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D018Oct 2019
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D019Oct 2019
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D020Oct 2019
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D021Oct 2019
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D022Oct 2019
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D024Nov 2019
NDC 13668-328-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/160mg/25mg, 30 TabletsBBX9D001Feb 2019
NDC 13668-326-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 5mg/160mg/12.5mg, 30 TabletsBBY1C002Sep 2018
NDC 13668-326-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 5mg/160mg/12.5mg, 30 TabletsBBY1E002Mar-2020
NDC 13668-326-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/160mg/12.5mg, 30 TabletsBBY2D001Feb 2019
NDC 13668-326-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/160mg/12.5mg, 30 TabletsBBY2D002Nov 2019
NDC 13668-207-30Amlodipine and Valsartan Tablets 5 mg/160 mg, USP, 30 TabletsBV53D004Oct 2019
NDC 13668-206-30Amlodipine and Valsartan Tablets 10 mg/160 mg, USP, 30 TabletsBV65D002Oct 2019
NDC 13668-204-30Amlodipine and Valsartan Tablets 10 mg/320 mg, USP, 30 TabletsBV77D013Oct 2019
NDC 13668-205-30Amlodipine and Valsartan Tablets 5 mg/320 mg, USP, 30 TabletsBV84D010Oct 2019
NDC 13668-205-30Amlodipine and Valsartan Tablets 5 mg/320 mg, USP, 30 TabletsBV84E001Dec 2019
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D001Dec 2018
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D002Dec 2018
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D009Mar 2019
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D010Apr 2019
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D011Apr 2019
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D012May 2019
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D013May 2019
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D014Aug 2019
NDC 13668-328-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/160mg/25mg, 30 TabletsBBX9D002Mar 2019
NDC 13668-328-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/160mg/25mg, 30 TabletsBBX9D003Jul 2019
NDC 13668-326-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 5mg/160mg/12.5mg, 30 TabletsBBY1D001May 2019
NDC 13668-329-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 5mg/160mg/25mg, 30 TabletsBBY4D001Apr 2019
NDC 13668-329-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 5mg/160mg/25mg, 30 TabletsBBY4D002Apr 2019
NDC 13668-329-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 5mg/160mg/25mg, 30 TabletsBBY4D003Jun 2019
NDC 13668-068-90Valsartan Tablets, USP, 80 mg, 90 TabletsBV46C007Sept 2018
NDC 13668-068-90Valsartan Tablets, USP, 80 mg, 90 TabletsBV46C008Oct 2018
NDC 13668-068-90Valsartan Tablets, USP, 80 mg, 90 TabletsBV46C009Oct 2018
NDC 13668-068-90Valsartan Tablets, USP, 80 mg, 90 TabletsBV46C010Oct 2018
NDC 13668-068-90Valsartan Tablets, USP, 80 mg, 90 TabletsBV46C011Nov 2018
NDC 13668-068-90Valsartan Tablets, USP, 80 mg, 90 TabletsBV46C012Nov 2018
NDC 13668-069-90Valsartan Tablets, USP,160 mg, 90 TabletsBV47C005Sep 2018
NDC 13668-069-90Valsartan Tablets, USP, 160 mg, 90 TabletsBV47C006Sept 2018
NDC 13668-069-90Valsartan Tablets, USP, 160 mg, 90 TabletsBV47D001Dec 2018
NDC 13668-070-90Valsartan Tablets, USP, 320 mg, 90 TabletsBV48D001Dec 2018
NDC 13668-070-90Valsartan Tablets, USP, 320 mg, 90 TabletsBV48D002Dec 2018
NDC 13668-207-30Amlodipine and Valsartan Tablets 5 mg/160 mg, USP, 30 TabletsBV53C006Nov 2018
NDC 13668-207-30Amlodipine and Valsartan Tablets 5 mg/160 mg, USP, 30 TabletsBV53D001Feb 2019
NDC 13668-207-30Amlodipine and Valsartan Tablets 5 mg/160 mg, USP, 30 TabletsBV53D002Feb 2019
NDC 13668-207-30Amlodipine and Valsartan Tablets 5 mg/160 mg, USP, 30 TabletsBV53D003Sep 2019
NDC 13668-206-30Amlodipine and Valsartan Tablets 10 mg/160 mg, USP, 30 TabletsBV65C002Sep 2018
NDC 13668-206-30Amlodipine and Valsartan Tablets 10 mg/160 mg, USP, 30 TabletsBV65C003Oct 2018
NDC 13668-206-30Amlodipine and Valsartan Tablets 10 mg/160 mg, USP, 30 TabletsBV65C004Nov 2018
NDC 13668-206-30Amlodipine and Valsartan Tablets 10 mg/160 mg, USP, 30 TabletsBV65D001Aug 2019
NDC 13668-204-30Amlodipine and Valsartan Tablets 10 mg/320 mg, USP, 30 TabletsBV77C001Oct 2018
NDC 13668-204-30Amlodipine and Valsartan Tablets 10 mg/320 mg, USP, 30 TabletsBV77D001Feb 2019
NDC 13668-204-30Amlodipine and Valsartan Tablets 10 mg/320 mg, USP, 30 TabletsBV77D002Feb 2019
NDC 13668-204-30Amlodipine and Valsartan Tablets 10 mg/320 mg, USP, 30 TabletsBV77D003Feb 2019
NDC 13668-204-30Amlodipine and Valsartan Tablets 10 mg/320 mg, USP, 30 TabletsBV77D004Feb 2019
NDC 13668-204-30Amlodipine and Valsartan Tablets 10 mg/320 mg, USP, 30 TabletsBV77D005Feb 2019
NDC 13668-204-30Amlodipine and Valsartan Tablets 10 mg/320 mg, USP, 30 TabletsBV77D006Feb 2019
NDC 13668-204-30Amlodipine and Valsartan Tablets 10 mg/320 mg, USP, 30 TabletsBV77D007Feb 2019
NDC 13668-204-30Amlodipine and Valsartan Tablets 10 mg/320 mg, USP, 30 TabletsBV77D008May 2019
NDC 13668-204-30Amlodipine and Valsartan Tablets 10 mg/320 mg, USP, 30 TabletsBV77D009Aug 2019
NDC 13668-204-30Amlodipine and Valsartan Tablets 10 mg/320 mg, USP, 30 TabletsBV77D010Sep 2019
NDC 13668-204-30Amlodipine and Valsartan Tablets 10 mg/320 mg, USP, 30 TabletsBV77D011Sep 2019
NDC 13668-204-30Amlodipine and Valsartan Tablets 10 mg/320 mg, USP, 30 TabletsBV77D012Sep 2019
NDC 13668-205-30Amlodipine and Valsartan Tablets 5 mg/320 mg, USP, 30 TabletsBV84C011Oct 2018
NDC 13668-205-30Amlodipine and Valsartan Tablets 5 mg/320 mg, USP, 30 TabletsBV84D001Jan 2019
NDC 13668-205-30Amlodipine and Valsartan Tablets 5 mg/320 mg, USP, 30 TabletsBV84D002Jan 2019
NDC 13668-205-30Amlodipine and Valsartan Tablets 5 mg/320 mg, USP, 30 TabletsBV84D005Feb 2019
NDC 13668-205-30Amlodipine and Valsartan Tablets 5 mg/320 mg, USP, 30 TabletsBV84D006Feb 2019
NDC 13668-205-30Amlodipine and Valsartan Tablets 5 mg/320 mg, USP, 30 TabletsBV84D007Feb 2019
NDC 13668-205-30Amlodipine and Valsartan Tablets 5 mg/320 mg, USP, 30 TabletsBV84D008May 2019
NDC 13668-205-30Amlodipine and Valsartan Tablets 5 mg/320 mg, USP, 30 TabletsBV84D009May 2019

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 1-800- 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.

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