September 19, 2019
Torrent Pharmaceuticals has expanded its voluntary recall of Losartan Potassium Tablets USP and Losartan Potassium/Hydrochlorothiazide (HCTZ) Tablets USP to include five additional lots. Three of the lots are for losartan potassium, while two are losartan potassium/HCTZ.
The recalled products contain trace a nitrosamine impurity, N-Methylnitrosobutyric acid (NMBA), in excess of the FDA’S currently established limits. NMBA is considered a probable human carcinogen (a substance that may cause cancer).
Because losartan-containing products are used to treat serious medical conditions such as hypertension, patients should not stop their medication without first working with their doctor or pharmacist to switch to a new supply not included in the recall, or to alternative therapy. The risk of stopping losartan products suddenly may outweigh the risk of exposure to NMBA.
For general questions regarding product returns, consumers should contact Qualanex at 1-888-280-2040.
Patients who have medical questions or wish to report an adverse event that may be related to the use of the recalled products can contact Torrent Pharmaceuticals by phone at 1-800-912-9561 or by email at Medinfo.Torrent@apcerls.com. Patients should also contact their healthcare provider if they have issues that may be related to the use of losartan potassium or losartan potassium/HCTZ. Adverse events can also be reported to the U.S. FDA’s MedWatch program.
Further details of the recall can be found at the FDA’s website.
Benecard Central Fill has not dispensed any of the recalled product.