PhotoTorrent Pharmaceuticals Limited is recalling 14 lots of Valsartan/Amlodipine/HCTZ 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 plus hydrochlorothiazide, it is used to control high blood pressure.

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

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

The products can be identified by checking the product name, manufacturer details and batch or lot number on the bottle.

What to do

The company is arranging for return of all recalled products to Qualanex LLC, with instructions for returning recalled products given in a recall letter being sent out.

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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