Lupin Pharmaceuticals issued a voluntary recall of some blood pressure medication due to the potential presence of a nitrosamine impurity, according to a notice published on the Food and Drug Administration’s (FDA) website.
The recall, issued last week, includes one batch of 20-milligram Quinapril Tablets USP — G102929 — and three batches of 40-milligram Quinapril Tablets USP – G100533, G100534 and G203071, the notice said.
Consumers, wholesalers, distributors and retailers can find the lot number on the side of the label affixed to bottles.
Lupin Pharmaceuticals said, during recent testing, the presence of N-Nitroso-Quinapril had been "observed" at a level "above the acceptable daily intake (ADI) level."
The recall includes one batch of 20-milligram Quinapril Tablets USP — G102929 — and three batches of 40-milligram Quinapril Tablets USP – G100533, G100534 and G203071. (Credit: FDA)
Nitrosamines, which are commonly found in water and certain foods, "may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time," according to the recall notice. The company said all people are "exposed to some level" of these impurities.
There haven't been any illnesses related to the recall reported to Lupin so far, according to the notice. The affected tablets, distributed across the country, are for high blood pressure treatment.
People taking 20-milligram or 40-milligram Quinapril Tablets USP should continue taking their medication and consult their medical providers for an alternate treatment, Lupin Pharmaceuticals said.
In addition to a written recall notice, the company is calling wholesalers, distributors, drug chains, mail order pharmacies and supermarkets to let them know about the recall. Lupin Pharmaceuticals said in the release they should "immediately" stop distributing the affected tablets.
It is also making arrangements for all the affected batches to be returned, according to the notice.