Rx Import Alert: CVS Branded Generic Drugs Singled Out In Bloomberg Report For Most Recalls

One of the examples used in the report was CVS Health branded eye drops. The report did not say who made these eye drops, but considering the incident they referred to – of a New York consumer who purchased the eye drops in November 2023 – had occurred during a nationwide recall of imported eye drops, they were likely made in India.

Last year, at least four deaths and several cases of vision loss from tainted eye drops were linked to imports from India.

CVS, Walmart, Walgreens, Rite-Aid, and every other pharmacy across the country, are not in the business of making drugs. They are purchasers of drugs made in contracted labs and they simply slap their logo on the packaging. Retailers will argue that they are not responsible for the quality of the drugs sold in stores. They rely on their contract manufacturer for quality, and the Food and Drug Administration’s inspectors who are supposed to make sure those labs are following the Current Good Manufacturing Practices set forth by the FDA for labs selling medicine into the U.S. market. 

The manufacturers themselves are responsible for the quality of the drugs, according to FDA guidance, and are the ones who voluntarily recall products when they find something wrong with them, or receive complaints from doctors or patients.

Some 80% of generic drugs sold in the U.S. are imported.

Since 2014, CVS hired at least 15 contract manufacturers – including some in the U.S. – that received lackluster results from FDA inspections. Bloomberg reported that CVS partner labs were twice as likely to receive requests for improvements to their lab practices as Walgreens. There have been some 133 recalls of CVS store-brand drugs — an average of more than one a month — in the last 10 years. Walgreens had 70 recalls over the same period and Walmart had 51, according to Bloomberg. 

In February 2023, a lab in Xiamen, China that made burn cream for the CVS Health brand was given an FDA Import Alert notice, banning the company’s Benzalkonium Chloride cream due to microbiological contamination. 

Sun Pharmaceutical Industries of India recalled their CVS Health generic version of Allegra this January after FDA investigators found stagnant liquid inside an air purification unit during a December inspection. Poor air quality can lead to spores that contaminate the lab, and taint the drugs.

The FDA generally does not ban imports from foreign labs that have received lackluster inspection results.  This is mostly due to concerns about supply back home. The FDA is constantly weighing supply concerns with safety concerns and unless the drug is a known hazard, supply concerns win out.

Over 320 drugs are currently considered to be in short supply or unavailable in the U.S., based on industry data.

With companies under pressure to keep generic drug prices low so hospitals and large pharmacies like CVS will keep buying from them, there’s little incentive to manufacture domestically, where the FDA has a much stronger footprint than they do abroad. 

“This sole emphasis on cost pushes the price down to the point where high-quality manufacturers don’t want to stay in the market,” Kevin Schulman, professor of medicine at Stanford University, told Bloomberg.