Only one lot of the medication is covered under the recall. It has lot/batch number BLM715A and an expiration date of July 2019, according to the FDA.
The drugs contain too much N-nitroso-diethylamine (NDEA), which has been classified as a probable human carcinogen, according to the FDA. The recalled medications, used to control high blood pressure and heart failure, were found to have NDEA above the acceptable daily intake levels released by the FDA.
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Macleods is notifying its distributors and customers and is arranging for the return of all recalled products. It is also coordinating returns with retailers, wholesalers and consumers.
Patients on the medication are advised to continue taking the tablets and to contact their doctor for advice.
“The risk of harm to a patient’s health may be higher if the treatment is stopped immediately without any comparable alternative treatment,” the company said.
This recall is the latest in the past few months. Since July, the FDA has announced voluntary recalls from Major Pharmaceuticals, Solco Healthcare, Teva Pharmaceuticals Industries and Mylan Pharmaceuticals.