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Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets




URGENT!!!            ADDITIONAL NDCS ADDED!!!            URGENT!!!



Description Lot Number  Expiration Date NDC UPC
AMLOD+VALS TB 10/320MG TORR30 BV77D013 10/31/2019 13668020430 31366820430
AMLOD+VALS TB   5/160MG TORR30 BV53D004 10/31/2019 13668020730 31366820730
AMLOD+VALS TB   5/320MG TORR30 BV84E001 BV84D010  12/31/2019 10/31/2019 13668020530 31368820530
AMLOD+VALS TB 10/160MG TORR30 BV65D002  10/31/2019 13668020630 31366820630


Torrent is voluntarily recalling the above items/lots due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. This recall is to the Consumer level.  Affected product started shipping August 20, 2015.

Consumers: If you have any medical questions regarding this recall, please contact Torrent Pharma Inc. at 1-800-912-9561. If you have any general questions regarding the return of this product please contact Qualanex at 1-800-505-9291.

This recall is being conducted with the knowledge of the FDA.

Contact:

Medinfo.torrent@apcerls.com: Torrent Pharmaceuticals Ltd 800-912-9561