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Torrent Pharmaceuticals Limited has extended the voluntary nationwide recall of its Losartan Potbadium Tablets, USP and Losartan Potbadium and Hydrochlorothiazide Tablets, USP due to consumer-level detection of trace amounts of blood. 39, an unexpected impurity found in an active pharmaceutical ingredient manufactured by Hetero Labs Limited.
The recall was expanded to include a further 36 batches of Losartan potbadium tablets, USP and Losartan potbadium and hydrochlorothiazide tablets, USP due to an impurity in NMBA's IPA. Only recalled lots containing NMBA above the daily absorption levels published by the FDA; no adverse events related to this recall have been reported.
Losartan is used to treat hypertension, hypertensive patients with left ventricular hypertrophy and nephropathy in patients with type 2 diabetes; USP tablets, Losartan potbadium and hydrochlorothiazide are used to treat hypertension and hypertensive patients with left ventricular hypertrophy.
These products have been distributed nationwide to wholesale customers, repackaging companies and savvy retailers. Those with medical questions regarding the recall or who need to report an adverse event can contact Torrent at 1-800-912-9561.
This is a long list of products concerned, links are available for reminders:
Original reminder: https://www.fda.gov/Safety/Recalls/ucm628966.htm
Extended reminder: https://www.fda.gov/Safety/Recalls/ucm629261.htm
Extended reminder: https://www.fda.gov/Safety/Recalls/ucm629693.htm
Extended reminder: https://www.fda.gov/Safety/Recalls/ucm632509.htm
Extended reminder: https://www.fda.gov/Safety/Recalls/ucm636296.htm
General questions regarding the return of the product can be directed to Qualanex at 1-888-280-2040.
Anyone taking this medicine should contact their doctor if they have problems that may be related to taking this product. Patients taking this medicine should contact their pharmacist and doctor for advice on alternative treatments before returning any medicine. Adverse reactions or quality problems can be reported to the FDA at 1-800-332-1088.
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