USA health regulators said on Friday a third cancer-causing toxin was found in some blood pressure pills recalled by India's Hetero Labs Ltd a day earlier, adding to a global recall of commonly used drugs to treat hypertension.
The agency's latest alert includes drugs that contain a potentially carcinogenic "impurity", though no adverse effects related to the recall have been reported.
The contaminant in Camber's drug, known as N-Nitroso N-Methyl 4-amino butyric acid (NMBA), was detected in an active pharmaceutical ingredient manufactured by an Indian company, Hetero Labs.
The U.S. Food and Drug Administration weighed in on the recalls of multiple generic angiotensin II receptor blocker, or ARB, drugs, on Friday, saying the impurities may be the result of chemical reactions that occur in the drugmaking process or from the reuse of materials, such as solvents.
The impurity in the AurobindoPharma USA products is N-nitrosodiethylamine (NDEA), which is classified as a "probable human carcinogen".
Camber Pharmaceuticals is pulling about 56,000 bottles of Losartan.
This is the latest of more than 30 blood pressure medicine recalls.
In a statement, FDA Commissioner Scott Gottlieb explained that the agency has been carrying out a series of investigations for several months after various companies began announcing their voluntary recalls.
"We're continuing to share these testing methods with global regulators, industry and the public to help manufacturers and other regulators evaluate these products for any potential nitrosamine impurity". The full list can be seen here on the company's recall announcement on Thursday afternoon. "The FDA is committed to implementing measures to prevent the formation of these impurities during drug manufacturing processes in the future".
According to the FDA, "Not all ARB products contain NDMA, NDEA or NMBA impurities, so pharmacists may be able to provide an alternative medication not affected by the recalls, or health care professionals may prescribe a different medication that treats the same condition".
AurobindoPharma, which recalled 80 lots of Valsartan medicines that had too much NDEA in January, added another 38 lots of Valsartan and Valsartan with Amlodipine tablets Friday.