Torrent – Recall of losartan

Torrent ? Recall of losartan

? On January 3, 2019, Torrent announced a voluntary, consumer-level recall of some lots of losartan tablets due to the detection of trace amounts of an unexpected impurity, identified as Nnitrosodiethylamine (NDEA), found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs.

-- Previously on December 20, 2018, Torrent had recalled several lots/NDCs of losartan tablets for the same reason.

? NDEA 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 classification.

-- To date, Torrent has not received any reports of adverse events related to this recall. -- Refer to the FDA site for updates regarding angiotensin II receptor blocker recalls.

? The recalled products are listed below:

Product Description Losartan 25 mg tablets Losartan 50 mg tablets Losartan 50 mg tablets

Losartan 50 mg tablets

NDC# 13668-113-90 13668-409-10 13668-409-30

13668-409-90

Losartan 100 mg tablets 13668-115-10

Lot# (Expiration Date) 4O49C013 (9/2019) 4O50C005 (11/2019) 4L67C035 (10/2019) 4L67C035 (10/2019); 4L67C036 (10/2019) 4DK3C004 (4/2019); 4DU3C040 (10/2019); 4DU3E049 (5/2021); 4DU3E050 (5/2021)

? Losartan tablets are used for the treatment of hypertension (HTN); to reduce the risk of stroke in patients with HTN and left ventricular hypertrophy; and for the treatment of diabetic nephropathy with

an elevated serum creatinine and proteinuria (urinary albumin to creatinine ratio 300 mg/g) in patients with type 2 diabetes and a history of HTN.

? Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication. Patients who are on losartan should continue taking their medication, as the risk of harm to a patient's health may be higher if the treatment is stopped immediately without any alternative treatment.

? Patients should contact their healthcare provider if they have experienced any problems that may be related to using the recalled losartan.

? Anyone with an existing inventory of the recalled product should stop use and distribution, and quarantine the product immediately.

Continued . . .

? For more information regarding this recall, contact Torrent at 1-800-912-9561 or email Medinfo.Torrent@. Contact Qualanex at 1-888-280-2040 for general questions regarding return of the product.

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