There is another recall of blood pressure medications due to possible contamination by an impurity that could cause cancer. It is the third recall announcement this month and one of two dozen since July last year.
Teva Pharmaceuticals announced on Friday that it is collecting 35 batches of Losartan Potassium USP tablets. There are six batches of 25 mg strength and 29 batches of 100 mg strength.
The company says that the impurity is N-Nitrous-N-methyl-4-aminobutyric acid (NMBA). Teva said it was found in six batches of the Active Pharmaceutical Ingredient (API) manufactured by Hetero Labs Limited that is above the acceptable exposure limit of the Food and Drug Administration.
"Based on the information available, the risk of developing cancer in a few patients after prolonged use of the product can not be ruled out," said Teva recall, adding that it has not received any reports of adverse effects related to the recall.
Click this link to see a complete list of reclaimed lots, expiration dates, and information on how to return the products.
Customers are advised to continue taking the medicines until they can talk to a doctor about alternatives. Leaving medication can lead to immediate risks to the patient's health, Teva said.
The lots were sold to Golden State Medical Supply, which repacks the product under its own brand and distributes it in retail bottles of 30, 90 and 1,000 tablets, according to Teva.
Torrent Pharmaceuticals announced a recall on April 18 for 104 batches of Losartan tablets. Legacy Pharmaceuticals expanded an earlier recall six days later, a move the company said was motivated by a Torrent recall.
The FDA said impurities may be happening when specific chemicals and reaction conditions are present in the drug's API manufacturing process. It can also result from the reuse of materials such as solvents. The FDA has generally stated that the risk of cancer is low.
Getty Images / iStockphoto
var modules = [