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There is another reminder regarding drugs for high blood pressure due to possible contamination by an impurity that can cause cancer. This is the third reminder announcement of this kind this month and one of two dozens since last July.
Teva Pharmaceuticals announced Friday the recall of 35 batches of Losartan Potbadium USP tablets in bulk. There are six lots of 25 mg and 29 lots of 100 mg.
The company claims that the impurity is N-nitroso-N-methyl-4-aminobutyric acid (NMBA). Teva stated that it was found in six lots of the active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited in excess of the acceptable exposure limit of the Food and Drug Administration.
"Based on the information available, the risk of developing cancer in a few patients as a result of long-term use of the product can not be ruled out," Teva said in his recall, adding that he had not received any reports of adverse events related to the recall.
Click on this link to see the complete list of recalled batches, expiry dates and information on the product return procedure.
Clients are advised to continue taking the medications until they can talk to a medical provider about alternatives. Discontinuing this medication may result in immediate risk to the patient's health, Teva said.
The batches were sold to Golden State Medical Supply, which repackages the product under its own label and distributes in bottles of 30, 90 and 1,000 tablets, according to Teva.
Torrent Pharmaceuticals announced a recall on April 18 for 104 lots of Losartan tablets. Legacy Pharmaceuticals developed an earlier recall six days later, a decision that the company said was motivated by a Torrent recall.
The FDA has stated that impurities could occur when specific chemicals and reaction conditions are present in the API's manufacturing process of the drug. This can also result from the reuse of materials, such as solvents. The FDA has generally stated that the risk of cancer is low.
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