According to the report, numerous generic drugs manufactured by the pharmacy chain CVS have been recalled over the past decade after being found to have been produced in unsanitary conditions.
For example, CVS brand baby nasal spray was recalled because the machinery used to make it was also used to make insecticide. Bloomberg News reported Monday.
Another pediatric medicine used to relieve fever and pain was recalled after it was found to have been manufactured using contaminated water, according to Food and Drug Administration data seen by the outlet.
Over the past decade, CVS has recalled 133 over-the-counter generic drugs due to safety concerns, nearly twice as many as Walgreens and nearly three times as many as Walmart, and the analysis found that the retailer relied on low-cost manufacturing at the expense of safety and quality.
In 2019, FDA inspectors visited a Florida facility of UniPharma, a manufacturer contracted by CVS, where they reportedly found that water used in the drug manufacturing process contained bacteria that could be deadly to children with weakened immune systems.
CVS ended up recalling several over-the-counter generic drugs, including children’s cherry-flavored pain reliever, children’s mixed berry-flavored allergy relief and children’s pineapple-flavored cough syrup, all of which were made by a now-bankrupt Florida manufacturer.
A CVS spokesperson told Bloomberg News that the chain prioritizes “good manufacturing and ethical sourcing practices, as well as the ability to meet our rigorous standards and inspection practices.”
The spokesperson added that CVS’ store brands are “designed to maximize quality and safety, perform as intended, comply with regulations and delight customers.”
In her lawsuit against CVS, Joan Collins, 78, of Nassau County, claims that after using CVS-brand eye drops purchased at a local CVS pharmacy in November of last year, she began experiencing red, swollen eyes, headaches and double vision.
A month before Collins started using the eye drops, Food and Drug Administration Inspection An investigation found that the drug was being produced at a facility in India where workers walked around barefoot, paint was peeling from walls and samples showed signs of bacteria.
According to Bloomberg, the FDA issued a warning to consumers in late October not to use the eye drops, but Collins said the drops were still on store shelves at least two weeks later, so she bought some.
Collins filed the lawsuit in Brooklyn federal court on Jan. 30, alleging that even after months of taking the eye drops, her vision has not fully recovered.
According to the lawsuit, a doctor who examined Collins blamed her symptoms on eye drops, and she was hospitalized for a week.
In response to her lawsuit, CVS admitted that it sold the eye drops but denied that “the products at issue in this lawsuit suffered quality control problems, were unsanitary, or were in any way defective.”
CVS, which outsources the production of its eye drops to an Indian company, also denied responsibility for the manufacturing processes or quality control at the factories that make generic drugs.
The Washington Post has reached out to Collins and CVS for comment. Collins’ lawsuit is still pending.
“We look forward to gathering evidence about what CVS knew, and when, about the problems it had that put Americans’ eyesight at risk,” Collins’ Manhattan lawyer, Stephen J. Fearon Jr., told The Washington Post.
An FDA spokesperson told Bloomberg that drug companies that outsource production of their drugs are “legally responsible for the approval or rejection of the drug produced at the contract facility, including final shipment.”
But CVS is recognized by federal regulators as a “private label distributor,” meaning it hires other companies to manufacture generic drugs for it.
FDA guidelines leave loopholes for store-brand drugs, putting the onus on generic drug makers to adhere to quality standards.
According to Bloomberg, CVS outsources the production of generic drugs to at least 15 manufacturers that have been cited for problems.
