DRHOOK- Total recall: Drug companies face contamination issues

the handsome doctor John Hong

Bad batch of cookies? I've never been much of a baker. I can stir-fry anything and make a mean hot and sour soup. However, baking is something I leave to tourists on the beaches of Cape May— (who don't seem to have heard of sunscreen or umbrellas).

Because I got a KitchenAid mixer for my birthday, I made the unthinkable decision: bake a cake from scratch. I now understand why they call it "scratch." It took me two days to find all the ingredients for a devil's food cake, and I thought I had everything. However, I mistook my 9" baking pans to be 8" so my cake turned out flatter than Jack Nicholson's man-boobs. I had to scratch the cake.

What happens when your medicines have to be scratched due to errors?

Lipitor might be the #1 selling drug in the US, with over $7.5 BIIIILLION (say it Carl Sagan style) in sales in 2009. However, on October 29, 2010, Pfizer recalled 38,000 bottles of Lipitor due to a musty mold smell. If that weren't enough, Pfizer also had had to recall 191,000 bottles of Lipitor earlier in October, and 140,000 bottles in August for the same problem. (And we thought it was bad enough when Pfizer spent over $258 million on ads using Dr. Jarvik, who's not a cardiologist or even licensed to practice medicine.)

Johnson & Johnson has had several drug recalls in 2010 because of reported nausea and diarrhea after people took over-the-counter Tylenol or Benadryl. These products were found to contain small amounts of a compound 2,4,6-tribromoanisole that's used to treat wooden pallets commonly used to store and ship bottles. Even as recently as October 18, more Tylenol was recalled due to contamination by this substance. 

Guess where more 2,4,6-tribromoanisole has been found? In the Pfizer manufacturing plant in Puerto Rico. 

On October 27, Sandoz Inc. recalled 24 lots of Methotrexate injectables because of glass particles in the medicine. The glass vials were delaminating. I don't think they looked like a snow globe tourists buy in NYC or Paris, but if injected in the blood or nervous system, the glass particles could be lethal or cause damage to internal organs like the lungs and brain. Vessel damage from the glass flakes, localized swelling, and granulomas (a kind of scar tissue) could occur.

Three recalls by different pharmaceutical companies occurred between October 21 and 27: Standard Homeopathic Company recalled Hyland's Teething Tablets because they wanted to address some manufacturing processes. B. Braun recalled seven lots of Heparin API because of a contaminant, oversulfated chondroitin. And Actavis Inc. recalled 18 lots of Fentanyl Transdermal System 25mcg/hr because it was releasing the narcotic too fast, which could cause a rapid blood pressure drop, slower breathing (or no breathing!), and excessive sedation. Mind you, there aren't reported bad outcomes for these three companies this month.

Maybe I've been watching too many episodes of Damages, with Glenn Close, which makes me scratch my head and wonder whom you can trust. It does leave a sour taste in my mouth every time I hear about products that aren't up to snuff. 

Nonetheless, I do believe most medications are made properly. 

And even though I wanted to scratch my devil's food cake, the Ghirardelli frosting I made was superb! So I slopped it on my three slices of cake that looked like chocolate pancakes. I called my office ahead of time to be sure a wheelchair was ready to escort my crippled cake. Despite my disappointment with the cake, everyone ate the whole thing. I will make another one, with better quality control!


Dr. Hook cracks a joke or two, but he's a renowned physician with an interesting website, drjohnhong.com. Email him with your questions.