Pfizer Japan drawn into valsartan recall after finding API from Mylan is tainted

Pfizer building
Pfizer's Japanese unit has recalled a valsartan combination drug that it says is tainted with an impurity. (Tracy Staton)

The global recall of valsartan has now extended to Pfizer and to Japan, via Mylan and India.

According to a translated copy of its announcement, Pfizer’s Tokyo-based Japanese subsidiary said it is recalling from the country five lots of its blood pressure combination drug Amubaro because its API contains impurities that are probable carcinogens. The recall began Thursday.

"We sincerely apologize for the inconvenience and worry to many people such as patients and medical professionals from the bottom of our hearts and we will pay close attention to manufacturing and quality control to prevent recurrence," Akihisa Harada, president of Pfizer’s Japan unit said in a statement.

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The 760,000 tablets being recalled are combinations of valsartan and amlodipine besylate salt manufactured using an API from Mylan made at a plant in India. It said because of reports of contaminated valsartan it investigated its product and found that it contained both expected carcinogens, N-nitrosodiethylamine (NDEA) that exceeded the standard and a trace amount of N-nitrosodimethylamine (NDMA).  

RELATED: The valsartan carcinogen mess taught pharma a surprise manufacturing lesson. Will 2019 bring more?

Recalls of drugs containing valsartan API manufactured in India by Mylan began in November with the retrieval of 15 lots of its own valsartan drugs that contained NDEA above approved levels. That was followed by a recall by Teva of all lots of its valsatran products made with Mylan’s contaminated API. In December Mylan expanded its own recall to include all of the unexpired valsartan products it had made with the tainted API.

The sweep of the problem, however, is much wider than just Mylan-made drugs. The global recall of “sartans” began last summer when a U.S. drug manufacturer that was using the valsartan API manufactured by China’s Zhejiang Huahai Pharmaceutical tested it and discovered one of impurities.

RELATED: FDA's aggressive move on tainted 'sartan' leads to shortages

Since then, the FDA made a discovery: NDMA and the similar NDEA can be created in certain manufacturing situations for sartan drugs, including the reuse of solvents, a fact the agency had been completely unaware of before. The surprise findings set off global recalls by a number of producers of hundreds of lots of valsartan, irbesartan and losartan—ubiquitous drugs used to lower blood pressure. It led the FDA to an intensive investigation into how it could have happened and the dangers it posed to U.S. consumers.

Now the long list of recalls has caught up to supply, leaving some products in shortage and the FDA trying to decide how to balance exposure versus going without a medication. In a statement released late last month, FDA Commissioner Scott Gottlieb and CDER Director Janet Woodcock, both medical doctors, said the FDA has now decided that since the risk from the impurities is generally very small, patients should continue to take their meds, even recalled products, “until their pharmacist provides a replacement or their doctor provides an alternative treatment option.”

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