Macleods Pharmaceuticals Limited is recalling 32 lots of the popular blood pressure drug losartan after discovering trace amounts of a probable carcinogen.
The recalled losartan and potassium/hydrochlorothiazide combination tablets contained small amounts of N-nitrosodiethylamine, or NDEA, according to a company notice posted to the Food and Drug Administration’s website Wednesday.
“Based on the available information, the risk of developing cancer in a few patients following long-term use of the product cannot be ruled out,” the recall notice states.
The active drug ingredient was manufactured at Hetero Labs Limited in India, one of the overseas drug factories linked to repeated blood medication recalls since last July.
Macleods also recalled one lot of the losartan combination drug in February for the same reason. The company said in the statement that for this recall “it has not received any reports of adverse effects.”
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Health care professionals advise patients to consult with their doctors or pharmacists before discontinuing one of the recalled blood pressure medicines or finding an alternative treatment.
Discontinuing a recalled drug could cause more immediate harm than staying on the medication.
Consumers with medical questions or to report an adverse event can contact Macleods at 855-926-3384 from 8 a.m. to 5 p.m. EST.
For questions about returning the product, contact Qualanex via email at email@example.com or call 888-280-2046 from 7 a.m. to 4 p.m. CST weekdays.
Was your medicine recalled?
Here are the doses, lot numbers and expiration dates of the recalled medicine:
Losartan Potassium Tablets 50 mg:
- BLl711A, BLl710A, November 2019
Losartan Potassium and Hydrochlorothiazide Tablets 50 mg/ 12.5 mg:
- BLK719A, BLK720A, BLK721A, BLK722A, BLK723A, BLK724A, September 2019
- BLK725A, BLK726A, October 2019
- BLK804A, BLK806A, January 2020
- BLK825A, BLK826A, October 2021
Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 12.5 mg:
- BLM716A, BLM717A, July 2019
- BLM719A, BLM720A, August 2019
- BLM721A, BLM722A, September 2019
- BLM723A, BLM724A, BLM725A, October 2019
- BLM726A, November 2019
- BLM802A, BLM803A, December 2019
- BLM825A, BLM826A, BLM827A, September 2021
Contributing: Ken Alltucker
Follow Kelly Tyko on Twitter: @KellyTyko