About 30 million Americans swallow atorvastatin every day to lower their “bad” LDL cholesterol. In this article I will not get into the pros and cons of statins to reduce the risk of heart disease. You can read about that controversy at this link, however. This post is all about the most recent drug recall. Why have more than 140,000 bottles of atorvastatin been recalled across the United states?
What and Why Has Atorvastatin Been Recalled?
The distributor of this generic form of atorvastatin is Ascend Laboratories LLC of Bedminster, N.J. Do not assume that this product was made in the USA, though. Like so many pharmaceuticals these days, this atorvastatin was actually manufactured by Alkem Laboratories, Ltd in India. According to the FDA the “Reason for Recall” was:
“Failed Dissolution Specifications”
In other words, the drug did not dissolve correctly. This is a somewhat similar kind of problem that we detected with the “branded” generic antidepressant called Budeprion XL 300. The actual brand name was Wellbutrin XL 300. The generic bupropion formulation did not dissolve like the brand. We discovered the problem in 2007 and wrote about it at this link.
It took until October 3, 2012 for the FDA to announce that the generic Budeprion XL 300 was not bioequivalent to the brand name antidepressant Wellbutrin XL 300.
How Many Actual Pills of Atorvastatin Have Been Recalled?
The FDA has not provided meaningful data about how much atorvastatin has been recalled. You may think that more than 140,000 bottles may sound like a lot. But wait…we’re talking about pharmacy bottles that may hold 90, 500 or 1000 pills.
I have been trying to read the tea leaves on the FDA’s somewhat obscure announcement. I glean from news reports that 141,984 large bottles of 10 mg atorvastatin have been recalled. If we multiply 141,984 x 500 tablets, you get 70,992,000 pills. Given that some of those bottles actually contained 1,000 pills, the number could be higher.
But wait…that’s not all. It wasn’t just the 10 mg atorvastatin pills that have been recalled. It looks to me as if the 20 mg, 40 mg and 80 mg bottles have also been recalled. You can find the FDA announcement of the atorvastatin recall at this link. For the stronger atorvastatin bottles, the FDA offers the abbreviation N/A under the product quantity heading. I assume that means “Not Available,” which I do not find reassuring.
Other Drug Problems Beyond the Atorvastatin Recall:
A colleague of ours, Suzanne Robotti, is the founder of the Med Shadow Foundation. This organization has a consumer-friendly website that reports on generic drug problems. This week you will find out about another recall from Ascend Laboratories LLC and Alkem Laboratories Ltd. This recall involves the medication aripiprazole, used to treat schizophrenia and bipolar disorder. Read more at this link.
On the Med Shadow website you will also learn about some problems with azelaic acid gel, bevacizumab (generic for Avastin), and generic formulations of carbamazepine (Tegretol), chlorpromazine (Thorazine), dextroamphetamine (Dexedrine) and Sulfamethoxazole and trimethoprim (Bactrim) among others. Here is the link to Med Shadow.
Please do let family and friends know about why some atorvastatin has been recalled. Thanks for supporting our work.
