Things That Shouldn’t Blow Up: Drug bottles

You’ve seen drug ads on TV where at the end of the commercial there is a laundry list of every possible safety warning associated with the product.  Well, apparently, there might need to be a new one added: implosion.
That’s right.  Earlier this year, the FDA had found that drug manufacturer Sun Pharmaceuticals in Cranbury, NJ (Exit-8A) had bottles of the generic lipid-lowering medicine Gemfibrozil that were imploding on the shelves.  The best part is that Sun had known about the implosions for six months and done nothing about it. 

Needless to say, the FDA has made them recall the –errr – defective packages, but last week the agency also cited Sun for being “out of control” and not following standard Good Manufacturing Practices.
You think?
I’ve worked in the drug and biotech industry for a long time now, and I know the vast majority of people in it want nothing more than to help people, but good lord this just ticks me off.

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17 thoughts on “Things That Shouldn’t Blow Up: Drug bottles

  1. WTF?!?One of my Baxter bosses was sent to another facility (I think in Illinois) which has KILLED 73 PEOPLE due to bad mfg practices. 3 years later (when he went) they were still doing everything like they had before… paperwork stacked 4' deep on top of filing cabinets; complaint system out of control, etc.If I was even the receptionist at a business which KILLED 73 PEOPLE, I'd have to quit over quilt.

  2. Are we sure they were really imploding or did the reporter use the wrong word? I should think those bottles would have to be really well sealed and the chemical changes going on would have to be pretty impressive to cause an implosion, but I'll defer to you. You're the chemist.

  3. That is amazing! That is terrible that the manufacturer knew about the problem and did nothing. Did they just think that no one would notice??? That seems rather idiotic to me! Geeez.

  4. Side effects of Gemfibrozil sharp pain in your upper stomach (especially after eating);jaundice (yellowing of your skin or eyes);blurred vision, eye pain, or seeing halos around lights; orpain or burning when you urinate.IMPLOSION

  5. LeendaDLL — man, that's just an awful story! I mean, it's one thing to have errors in a process — but you have to be diligent about finding them AND diligent about correcting them!

  6. Hapa — likely it was the package and not the material — drug products are designed to be really inert and (perhaps ironically) have as long a shelf life as possible. Likely it was the packaging — my guess is that it's filled under negative pressure and that subsequent changes in temperature/pressure caused the bottles to rupture.

  7. that's what's freaking me out about my current project (I know work in laser eye surgery). i was talking about my major project a couple weeks ago, the one where I finally had a breakthrough and spent an entire week making documents updates… well, yesterday the s/w team informs me (not asks; informs) that they're going to go a completely different route. They haven't run their idea by anyone for approval, and it will mean another week of updates for me, but they're just out there having wild hairs and implementing them. They seem to forget that they're in a regulated industry now. It's keeping me What part of Abbott were you in?

  8. Wow – I hope that was a major citation they received. Knowing about a problem like this and not doing anything about it SCREAMS lack of control. Event reporting, anyone? Process control, anyone? What’s interesting to me is the fact that this was an issue that was quite visible to the general public. Makes you wonder what kinds of problems they have that aren’t visible to the public – probably some much larger ones.

    (Note to self: find out who manufactures the drug I’m on…)

    I have to admit though, I’m curious as to what an imploded bottle actually looks like….

    • Yeah — I think one thing you can believe is that this just isn’t probably an isolated incident — if it had been, I’d think they’d have been more on top of it. This suggests they have problems all the time that get ignored.

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