Indian Drug Giant Lupin Issues Recalls for Several Products
Indian generic drug manufacturer, Lupin Pharmaceuticals, voluntarily recalled one batch of 20-milligram Quinapril Tablets USP — G102929 — and three batches of 40-milligram Quinapril Tablets USP – G100533, G100534 and G203071, the company told the Food and Drug Administration last month.
Consumers, wholesalers, distributors and retailers can find the lot number on the side of the label affixed to bottles.
The decision to pull the lot of blood pressure generics from the market was due to a discovery of increased amounts of nitrosamines in the drugs. Nitrosamines are a common cause of voluntary recalls. Taken in large quantities over time, these are carcinogens that could, in worse case scenarios, damage healthy cells and give rise to cancer cells.
Pulling the medication from the market will be up to Lupin, doctors, and pharmacies. Recalls are generally not managed by the FDA unless the FDA itself finds a drug impurity and instigates the recall.
Lupin’s recall marks a long list of Indian generic drug manufacturers that have pulled medicine from American pharmacies and doctors offices in 2022.
Last year ended with Indian labs leading the recall numbers, and headlines of drug shortages. The most prominent shortage was the infamous Abbott Labs’ baby formula shortage after a whistleblower complaint forced the FDA to close the lab temporarily.
Towards the end of the year, everyone learned about the shortage of amoxycillin, an important drug used to clear up pneumonia and other bacterial infections. There is only one lab in the U.S. that makes baby formula and only one lab in the U.S. that makes amoxycillin.
The bulk of America’s essential drugs come from Europe, Israel, India and, increasingly, China.
Lupin Recall is Another Warning Sign
The U.S. is heavily dependent on foreign drug manufacturers for many of our essential medications. This dependency is the result of heavily subsidized overseas drug producers and the lower cost labor of countries like India, where pharmaceuticals are the No. 1 manufactured good that India exports to the U.S.
The United States is reliant on imports for at least two-thirds of its generic drug needs, which is one reason why the FDA generally takes a hands-off approach to drug recalls. If the FDA recalled more drugs from foreign labs, the U.S. would risk drug shortages as many people rely on imported drugs daily. U.S. consumers on prescription medication are at the mercy of foreign producers to catch errors in their mixes and notify the proper channels to take the product off market.
The U.S. is a huge pharmaceutical producer and exporter. Most of our production is for the local market. But that market is increasingly served by contract manufacturers abroad, and the overseas generic drug makers. The U.S. is the world’s biggest pharmaceuticals importer. Last year, the U.S. imported over $85 billion in pharmaceutical goods. That’s more than crude oil imports, and almost as much as computer imports.
For Quinapril users with questions or concerns: contact Inmar Rx Solutions Inc. at (877) 538-8445 from Monday–Friday, 9 a.m. to 5 p.m. EST.
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We are a group of doctors, patients, health care industry experts, and advocates fighting to ensure all generic medicines are safe, affordable, and always available. Unsafe generic drugs from foreign manufacturers in China and India have been sold in the U.S that have been contaminated with carcinogens and fake ingredients, fall apart when tested, and don’t work as they should. We are fighting back to ensure all generic medicines are safe, affordable, and always available. We want every American to be able to trust the generics they take—every pill, every vial, every time.