Macleods Recalls Losartan Potassium/HCTZ Tablets
February 25, 2019 – Macleods Pharmaceuticals has voluntarily recalled one lot of Losartan Potassium/ Hydrochlorothiazide (HCTZ) 100mg/25mg tablets due to trace amounts of N-nitrosodiethylamine (NDEA).
A probable human carcinogen (cancer-causing agent), NDEA occurs naturally in certain food, water, air pollution, and industrial processes. The levels found in the recalled product exceed the FDA’s currently established limits. At the time of the recall announcement, no adverse events had been reported.
Because angiotensin II receptor blockers (ARBs) like losartan potassium/hctz are used to treat serious medical conditions, the FDA recommends patients continue on the medication until they receive a replacement product or switch to an alternative with the help of their healthcare provider. The risks of stopping treatment may outweigh the risks of NDEA exposure.
General questions related to the return of the recalled product can be directed to Qualanex at 888-280-2042 (7:00am to 4:00pm CST, Monday through Friday) or email@example.com. Adverse events that may be related to the recalled product should be reported to the patients’ healthcare provider, and can also be reported to the FDA’s MedWatch program.
Further details regarding the recall can be found at: https://www.fda.gov/Safety/Recalls/ucm631880.htm
Benecard Central Fill did not dispense medications impacted by this recall.