FDA Bans Import Of 30 Popular Generic Drugs

The FDA has banned the import of 30 different generic drugs made by Ranbaxy due to unresolved ongoing concerns about quality controls in the manufacturing process. Some of them are popular, like a generic for Zocor. The complete list inside. If you’re taking any of the affected drugs, keep taking them. The FDA found no evidence to suggest any consumers are at risk. If you have concerns, consult your doctor.

Here’s the drugs affected by the embargo:

Acyclovir
Cefprozil
Cefuroxime Axetil
Cephalexin
Ciprofloxacin HCl
Clarithromycin
Fenofibrate
Fluconazole
Fosinopril Sodium
Fosinopril Sodium and Hydrochlorothiazide
Gabapentin
Ganciclovir Sodium
Glimepiride
Isotretinoin
Lamivudine
Loratadine (OTC)
Metformin HCl
Nefazodone HCl
Nitrofurantoin; Nitrofurantoin and Macrocrystalline
Ofloxacin
Pravastatin Sodium
Ranitidine
Simvastatin
Terazosin HCl
Valacyclovir HCl
Zidovudine (PEPFAR)

Active Pharmaceutical Ingredients
Clarithromycin
Valacyclovir HCl
Pravastatin Sodium
Acyclovir
Ciprofloxacin HCl
Ganciclovir Sodium *
Gabapentin

These are the citations from the warning letters the FDA sent to Ranbaxy that were not resolved and prompted the import ban:

* The facility’s beta-lactam containment program (measures taken to control cross-contamination), which appeared inadequate to prevent the potential for cross-contamination of pharmaceuticals;
* Inadequate batch production and control records;
* Inadequate failure investigations; (A failure investigation is done to address any manufacturing control or product rejection to determine the root cause and prevent recurrence); and,
* Inadequate aseptic (sterile) processing operations.
* The lack of assurance responsible individuals were present to determine the firm was taking necessary steps under cGMP (current Good Manufacturing Practice);
* Inaccurate written records of the cleaning and use of major equipment;
* Incomplete batch production and control records; and,
* Inadequate procedures for the review and approval of production and control records for drug products

FDA Issues Warning Letters to Ranbaxy Laboratories Ltd., and an Import Alert for Drugs from Two Ranbaxy Plants in India [FDA] (Thanks to Chris!)

(Photo: Schodts)

Comments

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  1. Rectilinear Propagation says:

    Metformin HCl
    Ranitidine

    Well, OF COURSE!
    5 bucks says my doctor won’t be able to tell me squat.

  2. winstonthorne says:

    So am I jaded, or does this smell fishy to anyone else? I wonder who at the FDA is on the pharmaceutical companies’ payroll, and how much they’re getting.

  3. opsomath says:

    I wonder how much of this is due to Ranbaxy’s QC/QA procedures being worse than others, and how much due to American pharma companies pressuring the gov’t to kill competition.

  4. crazyasianman says:

    “If you’re taking any of the affected drugs, keep taking them. The FDA found no evidence to suggest any consumers are at risk.”

    wouldn’t it seem like there would be a higher chance of taking tainted drugs considering the risk factors created by the quality control issues?

  5. sleze69 says:

    So long as I can get my generic Viagra from Canada, I’m set.

    err…wait

  6. Trai_Dep says:

    …But the Extenze Penile-Enhancing pills are still okay right? RIGHT?!!

    • loueloui says:

      @Trai_Dep:

      Hey those aren’t penis enhancing drugs. Those are ‘male enhancement’ or maybe even mail enhancement. It would be immoral to mention those kinds of things on TV, so we’ll veil it behind a phony euphemism.

      Oh, and the fact that we can’t legally call it penis enhancement? That’s just a happy coincidence.

  7. ghstomahawks says:

    Hmmm… My first reaction to the headline was simply gee golly, what great news, they found where the rest of china’s melamine went! Of course, reading the story yielded the fact that the concerns were over quality controls which, while important, don’t exactly equate to anything necessarily being wrong.

    Then I realized that I take one of the generics listed. ****.

    All things considered, I think I’d like to know that when I put something into my body that’s supposed to alter the way it would naturally behave (as in medication, not food though it may apply) … I’d really like to know that the necessary steps were taken to ensure that it is what it’s supposed to be.

  8. ninabi says:

    FDA says, Shut up and take your medicine. The pills you still have left in the prescription.

    So, the problem was bad enough that new shipments were banned but not so bad that we can’t keep consuming the drugs?

    Was it just a little bit of dirt on the production line or am I consuming melamine in 300mg tablet form?

    • britne says:

      @ninabi: So, the problem was bad enough that new shipments were banned but not so bad that we can’t keep consuming the drugs?

      yeah, my thoughts. how do they know what’s at home in my medicine cabinet is safe?

      keep taking what you have, and whatever the pharmacy has on the shelf, then what?

      “consult your doctor” – yeah, like he’s going to have a better answer. well, the fda says to keep taking it, so you should. and/or, let’s switch that medicine to something else, something insurance doesn’t cover, perhaps?

      ^^is angry. takes one of the listed meds twice daily.

  9. DrJekyll says:

    One can continue taking a drug without taking the one manufactured by Ranbaxy. When you order or pick up your Rx make sure it’s not a Ranbaxy product if you’re concerned. Only one company makes a brand medicine. Many companies can make the generic.

  10. kmw2 says:

    Ranbaxy has been in trouble with the FDA since at least 2006, not only over production difficulties but over falsifying records on raw materials and not keeping appropriate cleaning records. It’s no conspiracy, at least one of the drugs on Ranbaxy’s import list isn’t even made by anyone else in the United States so there’s no competition. I only wonder why it took them this long.

  11. Shmoow94 says:

    Kmw2-Those are allegatations that have been yet to be proved, in fact some of those products are not even made in the facilities in question.

    In my opionion I feel like Ranbaxy was used as an example as there has been increased pressure on the FDA after a number of recent manufacturing issues have come to light in the past few years, not neccessarily dealing in pharma, but accross the board.

    Pharma is an area that FDA can flex on and it will have a ripple effect accross the market. Prices will increase for the generics as there is one less player in the market now and other generic firms have a rare chance to dictate the price.

    Although there could be an failure in proper paperwork keeping, the FDA obviously does not feel that any damage to humans could happen or a Recall would have been mandated.

  12. azntg says:

    First rate, top notch job as usual FDA! Who can say anything about always proactively protecting us all without accepting any bribes from big business first! *sigh*

  13. mrearly2 says:

    The FDA isn’t concerned about your health. The problem is that the drug companies want more of your money; the drug companies use the FDA to ensure they’re being properly enriched, by selling their poisons at top dollar.

  14. Phexerian says:

    This is not a case of bribes by big pharma. Most of the drugs listed are made as generics by other generic companies. Some of them I don’t even think they make a brand name for anymore. So why would big pharma pressure the FDA to do this if they can’t sell their brand name drug to make any money? Other generics on the market to compete with them and no brands for some.

    I’m assuming, that the FDA is telling us to keep taking these medications because they did a batch test to all of the drugs. On that batch test they can tell if the drugs are contaminated and what they are contaminated with. If those batches came clean, then there is no reason to stop taking the medications. The FDA is punishing Ranbaxy for not complying with the cGMP. Until they can show that they are complying with the cGMP, then they won’t be allowed to sell certain drugs here in the US.

    I do believe that there is a revolving door policy between the FDA and big pharma, but this doesn’t seem to show any collusions between the two.

    -Phex
    -3rd Year PharmD / MBA Candidate

  15. ageshin says:

    Bush’s FDA and big pharma are in an insestous relationship. A great revolving door where by people in the FDA retire into great jobs in the very pharma companies they are supervising. Ergo, big pharma doesn’t like generic meds and this ruling is in line with that. It’s the money baby, the money.

  16. Allura says:

    I will point out that I take one of the meds on the list (Metformin HCL) and it’s made by Apotex, not Ranbaxy. So there’s definitely other companies making them.

    Also, I’d rather have the FDA then, oh, China’s version of non-enforcement. I may pay more, but I’m fairly sure they ain’t gonna kill me.