New Recall Expansion Announced for Certain Losartan Products

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Torrent Pharmaceuticals has announced a new expansion of its recall for Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP to the consumer level. The recall is due trace amounts of an unexpected impurity, N-Methylnitrosobutyric acid (NMBA), detected during testing.¹

Losartan is used to treat hypertension, hypertensive patients with left ventricular hypertrophy and for the treatment of nephropathy in Type 2 diabetic patients.²

Torrent is only recalling lots of losartan-containing products that contain NMBA above the acceptable daily intake levels released by the FDA. The expanded recall includes the following products:¹

NDC 13668-409-10: Losartan Potassium Tablets, USP 50mg, 1000 count; batch 4DU2E009, and expiration December 31, 2020
NDC 13668-115-90; Losartan Potassium Tablets, USP 100mg, 90 count; batch 4DU3E009, and expiration December 31, 2020
NDC 13668-115-10; Losartan Potassium Tablets, USP 100mg, 1000 count; batch 4DU3E018, and expiration February 28, 2021
NDC 13668-116-90; Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count; batch BEF7D051, and expiration November 30, 2020
NDC 13668-118-90; Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count; batch 4P04D007, and expiration July 31, 2020

The affected products were distributed nationwide through Torrent’s wholesale distributor, repackager, and retail customers.¹

Patients who are taking Losartan 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, according to the FDA. Patients also should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.^{1, 2}

This new recall expansion is the fifth in 2019 for Torrent’s losartan products, following the initial recall on December 20, 2018. Recall expansions also were announced January 3, January 22, March 1, and April 18.¹ Some of the previous recalls were due to N-nitrosodiethylamine (NDEA) impurity.

Since July 2018, multiple companies have voluntarily recalled products containing valsartan, irbesartan, and losartan, stemming from concerns about levels of impurities, including NDEA and NMBA. According to the FDA, at least some of the impurities have been traced to active pharmaceutical ingredients manufactured by Hetero Labs Limited in India³ and Zhejiang Huahai Pharmaceuticals in China.⁴

In addition to Torrent, pharmceutical companies affected by these impurities include Aurobindo, Camber, Macleods, Mylan, and Teva. Numerous voluntary recalls have been announced in the last year, due to these impurities.

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REFERENCES

Updated: Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium / Hydrochlorothiazide Tablets, USP [company announcement]. Silver Spring, MD; September 23, 2019: FDA website. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/updated-torrent-pharmaceuticals-limited-expands-voluntary-nationwide-recall-losartan-potassium-0#recall-announcement. Accessed September 25, 2019.
Coppock K. Six Additional Lots of Losartan Tablets Recalled. Pharmacy Times website. https://www.pharmacytimes.com/resource-centers/cardiovascular-health/six-additional-lots-of-losartan-tablets-recalle-. Published January 23, 2019. Accessed September 25, 2019.
FDA: New Nitrosamine Impurity Detected in Certain Losartan Lots. Pharmacy Times website. https://www.pharmacytimes.com/resource-centers/cardiovascular-health/fda-new-nitrosamine-impurity-detected-in-certain-losartan-lots. Published March 2, 2019. Accessed September 25, 2019.
FDA provides update on its ongoing investigation into valsartan products; and reports on the finding of an additional impurity identified in one firm’s already recalled products [news release]. Silver Spring, MD; September 13, 2018. https://www.fda.gov/news-events/press-announcements/fda-provides-update-its-ongoing-investigation-valsartan-products-and-reports-finding-additional. Accessed September 25, 2019.