drug recall

Do you remember the book, Catch-22, by Joseph Heller? Airmen in World War II were faced with a no-win situation. To be exempted from a suicidal bombing mission you had to plead insanity. But if you asked to be grounded, there was “catch-22.” The doctor (Doc Daneeka) explained that, “Anyone who wants to get out of combat duty isn’t really crazy.” In other words, you were crazy to fly a suicidal mission but the moment you asked to be relieved you would be judged sane and have to fly. This sort of trap is what a patient is faced with when trying to file a report with the FDA based on the prescription drug label.

How Would You Know If Your Pills Were Recalled?

Have your blood pressure pills been recalled? Over the last several months, more than 600 lots of valsartan, irbesartan and losartan have been recalled due to contamination with a probable carcinogen. Each lot contains numerous bottles, some of which may contain as many as 1000 pills. We suspect that hundreds of thousands, if not millions, of pills have been recalled.

If you are concerned about whether your medicine is included in the recall, you may be surprised to learn that you probably can’t determine the lot number of your specific batch of pills. That’s because most pharmacies do not keep track of the specific lot of pills they dispense to any given patient.

The lot number is rarely, if ever, on the prescription bottle unless it is dispensed in the manufacturer’s original container. If the pharmacist took pills out of a big bottle and put them in a little bottle for you, the lot number is not even recorded in the pharmacy computer.

You read right! The pharmacist doesn’t have a clue what lot number she dispensed to you last week, last month or ever!

The Prescription Drug Label Is Inadequate!

When a can of tomatoes is recalled, the supermarket can alert you as long as you have your loyalty code on file. Computers are very good about keeping such records when the data are in the system. We have received a call from our supermarket when a specific lot of peanut butter was recalled. It was efficient. We were told to return the jar to the market for a refund. 

You might think that pharmacists would have the lot numbers of the medicines they dispense in their computerized systems. You would be wrong.

When a company like Aurobindo, Mylan or Teva recalls valsartan because of a contamination problem, the FDA lists the recalled products with their lot numbers at this link.  The implication is that a patient, pharmacist or physician could check a prescription drug label to see whether the pills inside were suspect.

Do Your Own Pharmacy Test of the Prescription Drug Label!

Good luck! If the pills were repackaged into a typical drugstore bottle, there will be no record of your precise lot number at the pharmacy. Don’t believe us? Do your own test!

Grab a typical pharmacy-dispensed bottle (one of those semi-transparent orange bottles with a hard-to-remove push-and-turn cap). Look for a lot number. If you can’t find one, call the pharmacist and ask her what lot number she has in her computer for that precise batch of pills. See what she says.

Catch-22 and the FDA’s 3500 Form!

The lot number becomes extremely important when a physician, pharmacist, nurse or patient wants to report an adverse drug reaction to the FDA. The agency encourages health professionals and patients to tell it about problems, “including serious drug side effects, product use/medication error, product quality problems, and therapeutic failures.”

MedWatch is purportedly interested in trouble that people may experience with over-the-counter as well as prescription drugs. Medical devices, cosmetics and foods or beverages are also included.

The 3500 Form the FDA makes available requires some very specific information. This allows the agency to follow up on an investigation. In addition to data about the problem you experienced, the form requests an expiration date, the NDC identifying number and the lot number.

Here is a link to the FDA’s main 3500 Form the “Adverse Event Reporting Program” for health professionals.

The MedWatch Consumer Voluntary Reporting (Form FDA 3500B) can be found at this link

If you go to either of those links you will see that part of the key information the FDA seeks is:

  • Expiration date (dd-mmm-yyyy)
  • Lot number
  • NDC number

The FDA states:

“Please complete all sections that apply to your report.”

“Dates should be entered as DD-MMM-YYYY (for example, October 12, 2016 = 16 OCT 2016).
 If exact dates are unknown, please provide the best estimate.”

The Missing Information on the Prescription Drug Label:

You won’t have any trouble finding a lot number and expiration date on your canned beans. Good luck getting a lot number for your lisinopril or levothyroxine.

As we just explained, the pharmacy doesn’t keep track of lot numbers. Unless you had some reason to ask for it when you picked up your prescription and kept track of it independently, you would have no way of knowing the lot number. Very few people go to this trouble.

The NDC number represents the National Drug Code. It is a unique 10-digit number that serves as a universal product identifier for drugs. It is required on every bottle of medication, but your pharmacy may use a bar code. That means you might not be able to translate it readily. The pharmacy can provide it, but you do have to make an effort to get that required information to fill out the 3500 Form.

The Missing Expiration Date on the Prescription Drug Label:

The expiration date is another hoop you have to jump through. There is a “discard after date” on your prescription bottle. In most states that will correspond to one year after the date the prescription was filled. It has nothing to do with the actual expiration date of your medicine.

If your pills were dispensed in the original manufacturer’s packaging, they will carry a true expiration date. But if your pharmacist took your pills from a big bottle to put them in a smaller container, the discard date is usually unrelated to the actual expiration date.

Filling out the 3500 Form is Challenging!

As a result of these serious flaws in current pharmacy dispensing practices, you cannot fill out a MedWatch 3500 Form accurately and completely. Some people are likely to feel as if they are caught in a catch-22 situation.

The FDA states unequivocally “Please complete all sections that apply to your report.” Many people might interpret that as check the prescription drug label, find the lot number, expiration date and NDC number. Since that information is not available on a repackaged pill bottle, some people may give up in disgust.

An FDA official tells us that they do accept reports that do not contain that information. Great. But that may not be obvious to everyone. A lot of wasted time could go into seeking information that is hard, if not impossible, to obtain. (For the record, the minimum information that has to go on a report is an identifiable patient, an identifiable reporter [these may or may not be the same person], a suspected product and an adverse event.)

Lack of lot numbers on prescription drug labels means that no one (not physicians, pharmacists, nurses or patients) can determine if a particular bottle of pills has been recalled. We find that unacceptable! Pharmacies need to demand that their software vendors change the software so this can be readily tracked.

Passing the Buck!

People at the FDA shrug their collective shoulders over these deficits. The agency says that the practice of pharmacy is not its problem. It claims no jurisdiction over what the pharmacist puts on the prescription drug label, even though the FDA issues drug recalls and asks for things like the lot number and expiration date.

Drug companies say that they comply with the legal requirement to put lot numbers, expiration dates and the NDC numbers on their original containers. They do not, however, have any responsibility if the pharmacist takes pills out of their big bottle and puts them in a little orange bottle. 

The pharmacist shrugs his shoulders and says that it’s not his problem. The computer program he uses does not offer the opportunity for including lot numbers or expiration dates in the record or on the prescription drug label. Those sorts of things are controlled by the state board of pharmacy and the chain drugstore that buys the computers and software that maintains labeling. It’s about time for these entities to seek out automated software that can track this information. There is nothing inherent about these data that would resist computerization.

What Do You Think?

Does this “system” make any sense? Do you feel caught in a catch-22 situation? Please share your thoughts in the comment section below. 

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  1. Marie
    cleveland ohio
    Reply

    This is the 3rd recall notice I’ve gotten. After the first two I was assured by 2 different pharmacists that my drug wasn’t on the list. This time it is. But I can’t check because it’s in the drug store orange script bottle, and there’s no way you cat get the batch number. It’s not on there. So I’m just gonna stop taking it, and call my heart Dr., and get a new script. i’m not messing around anymore with this. Unreal, just unreal….

  2. Marie
    OHIO
    Reply

    I had a recall on my BP meds 2 times already. The first time I had to go to the pharmacist and show him the bottle. It wasn’t on the first list. When the second recall came out I had a regular orange drug store bottle so I called the pharmacy and talked to the pharmacist who was so arrogant and rude to me. She said, “We checked all our bp meds, and I can guarantee you yours is not on the list. In fact none of our bp meds are on that recall list.” Yeah, right!

    So how come I got a 3rd notice in the mail today 5-4-2019, and my bBP meds are on the list. But once again I just got the orange pharmacy pill bottle, and there’s no way you can track your batch number because it’s not on it. So I’m just gonna call my heart Dr. and get a new script. I’m not dealing with the pharmacist any more Who knows who I’ll get this time. Every time it’s been a different pharmacist. The regular pharmacist I never get anymore nor do they give their names out to you when you ask. This is a major chain drugstore, for heaven’s sake.

  3. dr josafin p.
    New Jersey
    Reply

    Wow! My husband continued taking his valsartan because the companies involved were not ones listed. Now I wonder if he should have stopped and gotten a new RX. Problem is that every time they change manufactures or drugs we have trouble stabilizing his previously under-control blood pressure. Without a doubt a Catch-22.

  4. Amber
    Florida
    Reply

    Just yesterday I called my pharmacist to ask if she knew what lot numbers of Losartan they had been dispensing. She said they throw out the empty bottles as they’re dispensed so they have no idea if the pills they dispensed to me are ones that were recalled. I had to get a renewal RX from a different manufacturer through my doc, and the pharmacist seemed to get annoyed with my questions. It is a frustrating experience for someone who is concerned about their health and living with a chronic disease.

    I still have not heard that my RX is ready, and I don’t want to take tainted pills. Life is stressful enough already, and I now have the concern of developing cancer as a result of taking bad pills. I understand it’s not the pharmacists’ fault but you’d think there would be a better system of keeping people safe from bad drugs in place once they’re already dispensed.

  5. J
    Reply

    Here’s an idea: put one more task on that pharmacist who filling your prescription because clearly ALL they are doing is slapping a label on your bottle. That’s it…it’s EXACTLY what I spent 6 years in college getting my DOCTOR of pharmacy degree to do. Make sure we do it super quick too because YOUR time is way more important than safety when filling the 500+ prescriptions we do on any given day as the ONLY checking pharmacist.

    Tell me again…what do you do? Is it something that could kill a patient if you make a mistake? Is it something that you have lines of people staring at you frustrated because they are waiting in the line a mile long because these pharmacy chains find it more important to cut payroll than do what is actually necessary to take care of our patients? Does the phone ring non stop…do you have prescriptions dumping into your queue quicker than anyone could possibly complete in the never ending timer the company sets to complete them by? Do you have a degree that is the ONLY one that patients can walk up to at any time to get FREE medical advice…with complete disregard for the 100 other things going on behind that counter?!? No. Oh ok, I didn’t think so.

    But you are right…just ask that pharmacist to do one more thing!!! That’s right, if enough of you demand us to hand write your lot number on those bottles it won’t slow down the already sloth like process you all think we are already operating under.

    While I don’t disagree with you that this information should be much more trackable I caution you not to speak about what you don’t know, and possibly take a fraction of a second to have compassion for the pressures already being put on those pharmacists who are working 12+ hour days non-stop for YOU praying they don’t make a mistake that could HARM YOU.

    If you want all this done, then yes, reach out to your state board of pharmacy, pressure these retail pharmacy companies to treat their employees better if YOU want better service but do NOT..DO NOT take this out on your pharmacist or their technicians who are doing everything in their ability to take care of you. It is ignorant of you to think otherwise.

  6. Sandra
    Waller County, TX
    Reply

    As a retired pharmacist, my experience was that patients main concern is how fast the RX can be ready and what it will cost. Unless and until there is a problem, there are very few patients who will care if lot numbers or accurate expiration dates are on the label.

    Personally, I did try on some medications to put the actual expiration date on the label, but the data entry, actual dispensing from the stock bottle, and verifying pharmacist are rarely the same person(s). Also, there is so much information that is currently required to be on the label, they are already almost too large to fit on smaller RX bottles.

    The only feasible way that I see for true expiration dates and lot numbers to be tracked would be for a software system that allows a stock bottle to quickly and easily scan the stock bottle, or bottles, and then record it with the other information for that particular RX. I don’t know how it can be efficiently added to the label in pharmacies where one person does the data entry that produces the label that then goes to a second person who actually gets the stock bottle off of the shelf and fills the RX and often only then goes to the pharmacist for verification, often unaccompanied by the stock bottle (relying instead of an on-screen photo of the actual tablet or capsule.)

    Finally, for those who plan to request that information be provided, you need to request it BEFORE the RX is filled. Otherwise, the stock bottle is likely to be long gone with the trash.

  7. Ginger
    Oregon
    Reply

    I went to my pharmacist and asked a question about a medication I was taking.
    You had listed it as extremely dangerous and side effects could possibly even cause death.
    When I asked him he said we don’t get that medication from that country.
    He went back and looked and came back and said I was right. They did get it from that country.
    It is a medication I need but it has not been recalled from my pharmacy.
    So what do I do. If I need this medication and don’t have any other choice?

  8. Mae
    NY
    Reply

    I intend to request seeing the container my prescription for generic Valsartan is taken from the next time I fill the script and wait for them to count and bottle it. I will keep the lot number and MDC and expiration date if it’s there. If enough people do this, they might incorporate the practice. I’m on my 3rd, different batch of Valsartan, after the first 2 were recalled. The first time, I received the notice of recall from the pharmacy, one week AFTER I’d told them I heard about the recall on People’s Pharmacy.

  9. Ron S.
    Seattle
    Reply

    What about asking your druggist to put the NDC, expiration date, and lot number on each prescription you buy? If enough people start doing this, it will get to be such a bother that the pharmacist will ask that these things be done automatically. Also, I have kept drugs for over 10 years in sealed (from the drug store) containers, and they always have worked just fine. I do live in a moderate climate, so the drugs are not exposed to extreme heat for long periods which might cause the drugs to lose their potency. My old drugs have come in handy on occasion.

  10. Cathy
    North Carolina
    Reply

    The prescription label is a mess in a lot of ways. The generic and/or brand name should be in small print under the name of the prescription so that the patient can easily identify it. Often the MD/PA will use a brand name but prescribe the generic, and we have no way of identifying it easily. The label also has incorrect expiration date; no lot number and no manufacturer information. The directions are often in small print; the extra directions (with food, 1 hour before, etc) are on the side. And the drug information sheet they provide you with your RX is often in minute print and does not contain the class of drug or the brand and/or generic names.

    The FDA is lax in providing important instructions in easy to read, easy to understand language for the general public. Thank God for Google. It is a lifesaver in finding out information about prescriptions, but it should not be the go-to. That should be an automatic from the pharmacy.

  11. John
    Baltimore
    Reply

    What sense does it make to add exactly 1 year to the date you got your medicine as the expiration date? I can add 1 year myself; I don’t need the pharmacist to give me the same date for next year. The fact of the matter is that many drugs are good for years after the expiration date but the drug maker and the pharmacist want you to throw out the old drugs and pay for new ones.

  12. BBBob
    Amherst, NY
    Reply

    When the first recall of valsartan was announced, I was hopeful that the similar prescription, Irbesartan/HCTZ would not suffer the same fate, but called my healthcare provider, who informed me that my Irbesartan prescription was okay.

    However, two weeks ago, I was advised to contact the manufacturer/distributor of my Irbesartan prescription to provide them with the lot numbers of any bottles in my possession, and learned that the current 90 day supply of the prescription had been recalled, but only after I had used 75 of the 90 pills in that bottle. You might say that I was somewhat (if not greatly) annoyed at this discovery. So, what is the answer?

    The recent prescription refill is not on the recall list.

  13. Theodore
    New York
    Reply

    I am a retired pharmacist and totally agree that the lot number as well as the expiration date should be on all dispensed RXs. If we are truly concerned about patient safety then this is a must. My suggestion would be to write your state senator or representative. State requirements are easier to enact than those from a Federal entity.

    • Valerie Walsh
      WA
      Reply

      I am a retired registered nurse who worked 20+ as a state and federal health care inspector. In that role I identified medication safety deficiencies virtually everywhere I surveyed/inspected. Changes to laws on the local level DO work. We should not forget to engage our state Attorneys General, in addition to our local legislators. But Federal regulation is more effective overall in terms of enforcement, and we should definitely engage our state senators to work on needed changes. These types of changes typically come via amendments to the Medicare/Medicaid regulations. The reason these work is that they affect the pocket books of the providers. If they don’t play by the rules, they lose money.

  14. Debra
    Reply

    FDA continues to prove its complete uselessness, incompetence and obvious conflicts of interest in its mandated oversight of pharmaceutical, food supply and cosmetic industries. There is a revolving door for executives of these corporations and FDA as they go back and forth between them. Nothing will change unless and until a very powerful high profile politician or his/her family member is injured or dies as a result of FDA’s rampant failures. How sad.

  15. JOANN
    NC
    Reply

    I think the actual expiration date of the drugs should be on the RX container not the 1 yr date. Most drugs are good for longer than 1 yr. It frustrates me to not find the expiration date. It should be required.

  16. Jackie H.
    OH
    Reply

    I have been taking carvedilol for about a year with out any problems. Then my druggist changed their supplier and now I have heartburn, nausea and increased blood pressure. They told me it was the same meds.

  17. Carla
    Virginia
    Reply

    I think that this system benefits drug companies and that our so called representatives in congress have failed at yet another responsibility to protect the American People. Write your congressman and women and make them aware that you will be monitoring them for some responsible voting on this important issue.

  18. Emily
    NC
    Reply

    I received a letter from insurance company informing me I was taking a drug that had been recalled. I contacted my pharmacy and they stated they did not receive any of those lots. Should I feel secure?

  19. Jane
    CO
    Reply

    I wonder if anyone thinks this is inadvertent? The muddier the waters, the easier it is to hide problems. I, for one, am not the least bit surprised at the lack of available data. It seems obvious the FDA is far more concerned with the financial wellbeing of big pharma than the health of the patients.

  20. Laurie M.
    Waseca, MN
    Reply

    I think this is just absurd. Why can’t the FDA make it a requirement that Pharmacies must include the lot numbers on prescription labels? Oh I forgot, they will when someone dies from a contaminated medication that had no lot number on the bottle!!

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