For the second time this month, Torrent Pharmaceuticals expanded its recall of Losartan, a drug used to treat high blood pressure, a blood pressure-related heart problem and diabetes-related kidney issues.
Now, in addition to the 10 lots of Losartan potassium tablets, six lots of Losartan potassium and hydrochlorothiazide tablets also have been recalled.
The reason for Torrent’s original December recall, the Jan. 3 expansion and this one is the amount of N-nitrosodiethylamine (NDEA) in the active pharmaceutical ingredient. NDEA is classified as a “possible human carcinogen” by the International Agency for Research on Cancer.
“Torrent is only recalling lots of Losartan containing products that contain N-Nitrosodiethylamine (NDEA) above the acceptable daily intake levels released by the FDA,” the FDA-posted recall notice states. “To date, Torrent Pharmaceuticals Limited has not received any reports of adverse events related to this recall.”
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Patients are advised to keep taking their Losartan until their doctor or pharmacist comes up with another way to treat what the drug is addressing.
Here’s what’s recalled:
▪ Losartan Potassium, 100mg, 30-count bottles, lot No. BO31C016
▪ Losartan Potassium, 100mg, 90-count bottles, lot No. BO31C016
▪ Losartan Potassium, 100mg, 1,000-count bottles, lot Nos. 4DK3C004, 4DK3C005, 4DU3C040, 4DU3E049 and 4DU3E050.
▪ Losartan Potassium, 50mg, 30-count bottles, lot No. 4L67C305.
▪ Losartan Potassium, 50mg, 90-count bottles, lot Nos. 4L67C305 and 4L67C306.
▪ Losartan Potassium, 50mg, 1,000-count bottles, lot No. 4O50C005.
▪ Losartan Potassium, 25mg, 90-count bottles, lot No. 4O49C013.
▪ Losartan Potassium Hydrochlorothiazide, 50mg/12.5mg, 90-count, lot No. BP02C008
▪ Losartan Potassium Hydrochlorothiazide, 50mg/12.5mg, 1000-count, lot No. BEF7D006
▪ Losartan Potassium Hydrochlorothiazide, 100mg/12.5mg, 90-count, lot Nos. BX35C020 and BX35C049
▪ Losartan Potassium Hydrochlorothiazide, 100mg/12.5mg, 1000-count, lot Nos. BX35C022 and BX35C023
Customers with questions can call Torrent at 1-800-912-9561 24/7, but only calls received from 8 a.m. to 5 p.m. Eastern will get a live voice.