Questions about generic drug quality persist despite FDA reassurances. More than a year ago the Actavis Group had to voluntarily recall 800 million digoxin tablets because of doubts about the dose. A large Indian drug maker, Ranbaxy, also got into hot water because of allegations the company falsified data. The FDA banned importation of many Ranbaxy products as a result of its investigation. Other generic companies that have gotten into trouble recently include KV Pharmaceutical, Sandoz and Caraco. Over 100 different generic drugs have been recalled, resulting in short supply of certain medications such as the heart and blood pressure medicine metoprolol succinate.

Now, the largest maker of generic drugs in the U.S., Mylan, has been accused of failing to enforce adequate quality control procedures. Some workers apparently violated normal protocols to keep production lines running. According to the Pittsburgh Post-Gazette, the newspaper that broke the story, the unauthorized practices may have been going on for up to two years. The company produces nearly 20 billion doses each year. This comes on the heels of trouble at Mylan’s Indian subsidiary, Matrix Laboratories. The World Health Organization discovered major deviations in proper manufacturing practices last spring. All these drug problems are undermining confidence in the FDA’s ability to monitor generic pharmaceuticals. With increasing reliance on generic drugs to save money, it is imperative for the FDA to make sure that these lower-cost alternatives are absolutely equal to their brand name counterparts.

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  1. Dale W

    I also have issues with the generic psuedomedicinal manufacturing process. I have been informed by so called respectable grocery chain pharmacies that the reason they (read as corporate) won’t sell a specific brand of narcotic painkiller is because it had been deemed “most abused by addicts.” My response was with a question of “…do they realize why the addicts use that brand?? It is because it flippping works! Now I have to suffer with chronic dilibillitating pain due to greatly inferior generic medicine.” Needless to say, I still fight to this day for help. Time to take this to a higher level,people. We are paying good money for bad medicine and the doctors have to step in and help for they to allow this is a crime on thier part for they know this is happening, those in the pain management business. Doctors, do your job by the oath you took, for to do nothing with knowledge of whats going makes you just as guilty as the manufacterers and retailers selling the bad product for good money.

  2. jgw

    I am taking a new 10 mg of lovastatin from lupin mfg and I am having terrible cramps in my upper thigh area and the pain in my kidneys are very sharp….. Tried two different times and same reaction both times.
    I had been on 10 mg of lovasatin from actavis mfg with no side effect for 5 years… now can’t get it…..
    Lupin is selling all stores in this area, don’t know what to do?

  3. AB


  4. js

    How can I determine where a drug is manufactured?

    • ellie

      I thought it was just me! I take generic valium as needed and I used to be able to get by with 1/4 of a 10mg pill.. but the new script I got were from a different manufacturer and I can take a whole 10mg pill and not even get sleepy.

  5. Norma G

    If I knew the inactive ingredients or fillers (not the exact amounts of each) used in generic keppra, I myself could probably select one that I would not adversely react to and select that generic to try. I get multiple seizures within minutes of taking the generic keppra I purchased from Walmart’s. My cost in the year 2012 went from $40 to $477.00 for 180 pills per month for brand keppra. Brand keppra lists their inactive ingredients and fillers.
    I only get instant (within minutes) continued multiple seizures when I consume aspartame or caffeine.
    I have not been able to find a listing of the generic ingredents. They do differ, I understand, by various laboratories. My understanding is there are 28 different labs that make generic keppra.
    Where can I review the generic inactive ingredients and filers?
    People’s Pharmacy response: The pharmacy has a reference that can provide that information.

  6. sam

    According to a top industry expert, the generic drugs market in the U.S. would further flourish in the coming four years. This is because more brand name medications will be made available as lower-cost generics. Since several well-known drugs are about to lose their U.S. patent protection between 2011-2014, generic drugs market is expected to see a tremendous growth. This would also help the U.S health healthcare system to save a massive $70 billion in these four years.

  7. Anne W

    I realize I’m commenting almost a year later on this subject, but it’s very interesting because I have often complained about generic medicines that have been pushed by my insurance company. One time I was told that my feeling the generic drug wasn’t working was probably psychological because I knew it wasn’t a brand name! I told the pharmacist that I would love to pay less for the drug and generic was fine with me as long as it worked.
    It’s really frustrating to have to keep fighting to get the brand product and after reading this article and the comments that have been posted I feel even more frustrated!
    On the other hand I think we’ve all gotten kind of spoiled with the health insurance that was available to us in the past. I can remember a time when I paid practically nothing for any of my health care, including prescriptions. It’s difficult to have to pay so much out of pocket now, but it also seems like there’s so much more available and we’ve kind of come to feel a sort of entitlement.

  8. BF

    After taking Yasmin for a couple of years to treat my PCOS (Polycystic Ovarian Syndrome), they finally just came out with a generic version. It is not the same! After a couple of years of the brand name, I know my body and what should be happening, but without going into too much information, the generic was not working. (Started bleeding through in the middle of the cycle on generic birth control.) I should have one of the best insurances around because I am a teacher, but I now have to pay $30 in addition to my $20 copay for my prescription so that I may get the brand name.
    I heard that my district pays close to $1000 a month for my coverage and this is the best that the health care system can do for me?!? This is outrageous that we live in America and this is how our people are taken advantage of by big US health care corporations. I’m not sure how I feel about Obama’s health care plan, but anything different has to be better than what we have going for us now.

  9. Allie

    I would like to know if anyone knows of a place to send questionable generic drugs for testing to see if they contain the correct amount of active drug. I recently took generic minocycline which I suspect had much more active drug than stated. Also where can one find a list of fillers used in generic drugs? Maybe kbumga can help here.

  10. JMF

    The White House, taking a page out of the Bush administration on Medicare Part D, has agreed with Pharma not to negotiate prices in the health reform bill, or to import less expensive drugs from Canada. So where we go from here is lower quality, uncertain value in filling our prescriptions.
    Why is value for the money, government’s and ours, not a part of the reform discussions?

  11. pearl

    I recently had an RX for 2 MG of diazepam (generic valium) for anxiety and I filled it at CVS who uses Mylan Pharmaceuticals, and they did “NOT” work at all!. I contacted the manufacturer and CVS. All they did was refund my money. I have used valium for years before for acute anxiety.
    I wish that I could afford name brands for all of my medications to feel safe. But who can afford hundreds of dollars a month for just medications!
    Congress has got to do something soon to stop this kind of abuse. It’s killing people!
    Where do we go from here?!

  12. kbumga

    I am a pharmacist on medicare D (rx coverage). Many of the generic prescription drugs that I am forced to use are manufactured in India. I dread to think what will happen to quality if we are ever forced to use drugs manufactured in China. Most of the drugs from India seem to work well and are probably up to snuff. Anticonvulsants may present problems.
    Our pharmacy is on a contract managed generic buying program from the wholesaler; we cannot choose just any brand of generic–just the ones approved by the plan. I think all of this came about because of the $4 generic rx’s offered by many chain pharmacies. Quality is definitely secondary to cost.

  13. CW

    This is absolutely ridiculous!! If we are to put chemicals (pharmaceuticals) in our body, it better be exactly what it is supposed to be.

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