One of the world’s biggest drug companies has been caught cutting corners at a supposedly “sterile” facility for making common drugs.
An FDA warning letter finds that meds made at a Pfizer plant in Kentucky are contaminated with bits of cardboard and – I’m not even kidding here – floating brown chunks.
We’re just getting wind of it now, but the agency fired off the opposite of a love letter on Feb. 14, blasting the company for “significant violations of current good manufacturing practice” and declaring that drugs from the plant are now considered “adulterated.”
The plant, which Pfizer bought when it acquired Hospira in 2015, makes injectable drugs — including the antibiotic vancomycin, which had the pieces of cardboard in it.
How in the heck does that happen in a “sterile” facility? Or is Pfizer sharing space with an Amazon.com shipping center to save a few bucks?
The cardboard may not even be the worst of it.
The report also finds that vials of the injectable NSAID ketorolac tromethamine contained what the agency generously described as “brown agglomerates.”
What were they? WE DON’T KNOW!
The FDA said Pfizer “did not conduct a comprehensive assessment of the particulate matter.”
In other words, the company never did a thorough test to figure out what those poop-colored chunks were really made of.
Then, for the icing on the cake, Pfizer — even after they KNEW they had a problem — did almost nothing about it.
The company recalled the one with the cardboard bits, but not until a full four months after they found out about it. By then, you can bet most of the meds had already been used.
Patients could be unknowingly walking around with little cardboard bits inside them right now.
For the other drug, the company did even less than a too-little, too-late recall.
As far as we know, they did NOTHING since the FDA says Pfizer didn’t “document any corrective actions.”
The warning letter might have some tough words and even threats of “seizure and injunction,” but don’t congratulate the FDA for growing a spine and doing its job.
In reality, the letter has as much bite as a toothless hamster.
This is the FDA we’re talking about, after all, and the Feb. 14 letter wasn’t a prompt response to inspections held days or even weeks earlier.
They took place last May and June!
It took eight or nine months for the FDA to finally send off its strongly worded letter, and we know from experience that these letters aren’t usually followed by actions… but by still more letters.
Since neither the FDA nor the companies are forthcoming about things, it’s up to you to protect yourself – and the best way to do that, of course, is to make sure you ONLY take medications when you absolutely NEED them.