I just got a letter from my health insurance’s mail-order pharmacy, about Pfizer recalling some of their birth control. I get my prescription filled in 3-month sets, and am currently on the first of three. That is, I’m on the placebo pills, but I never bother taking them, I just go a week without taking anything, and then start the next pack.
So when I got the letter yesterday, I compared the lot number from my just-finished pack (and the next 2 packs) with the list, and of course it was on the list of affected batches. So of course I was starting to freak out. I did some Googling and found this Huffington Post article. The article seems to say that if you have one of the defective packs, it would be obvious because the placebo pills are a different color (they are pink, while the active ones are white).
I felt relieved then - I had been thinking that the colors were also mixed up, meaning you wouldn’t know which pill you had taken. But I am 100% positive that all the pills I had taken were white. And looking at my other two packs, the white and pink pills are all in the correct order. So…does that mean it’s all good? I do plan on calling the mail-order pharmacy too, but I just wanted to get a second opinion on whether I am interpreting this article correctly. It is from the Canadian HuffPo site, and I couldn’t find any articles on their American site commenting about the pill color issue.
May I ask what the letter said? Did it specify certain brands/chemical names? Usually letters like this include a URL to some web page with details … did this one have anything like that? And what do they say to do if you DO have the recalled batch … dispose? return to pharmacy for refund/replacement?
Just curious about the details. I don’t know nuthin’ about this, either, but I’m hoping some details would improve Google searches.
The letter itself is fairly long, but I’ll quote the most relevant parts:
Not sure why it refers to “Akrimax” since the pharmacy is Medco and the manufacturer is Pfizer. It goes on to say:
So the letter didn’t say anything about the pill color. It seems to be saying that you should consider all pills from those lots to be affected - better safe than sorry, I guess. But they said nothing about returning the pills, only that you can’t get more for 6-8 weeks. So I guess if you got bad pills, you’re out of luck for 2 months? That’s one reason I’m going to call the pharmacy, to find out about getting a replacement, or at least getting my money back on the ones I was sent.
I’m due to get my period sometime tonight or tomorrow morning, based on my pill schedule. So if it comes as usual, then I don’t have to worry so much. (I know there’s never a good time for an unwanted pregnancy, but this is really really not a good time, as I’m dealing with a long-term injury, and we are moving into a new house and money is tight.)
Assuming I do get my period, if I at least knew that my next 2 packs of pills were okay, I wouldn’t have to deal with using another method while I wait to get more.
Ok WTF, It says that lo/Ovral and the generic were affected. However there are TWO branded generics for Lo/Ovral (Cryselle and Low-Orgestrel) neither of which is manufactureed by Pfizer
it does not SEEM that either “brand generic” is included in the recall but it’s very hard to tell. Low-Orgestrel is manufactureed by Watson Pharma.
So I think I’m good. Plus, if I had taken a colored pill out of sequence I would definitely have remembered it. I don’t bother taking the colored pills, and also I’m not stupid, I know the colored pills are placebos. I’ll check lot numbers when I get home. Plus I just finished my period so obviously, for now I’m good.
NOTE: I do not work for Pfizer, but I have done quality control and release drug testing. I am not familiar with this particular recall beyond this thread and the linked news article.
There is pretty much no chance of a colour mix up - if the placebos are supposed to be pink and the actives are supposed to be white (or whatever) then the pink pills are placebo and the white ones are active. This will have been tested and verified *prior to packaging *as part of the quality control protocol. The tablets you have are the correct doses and safety; what you might not have is the correct amount of each, or in the correct order.
This recall is explicitly a packaging error, not a manufacturing one. The risk is that if someone doesn’t notice the change in colour, they will be getting a variable amount of hormone, perhaps similar to skipping a day, and therefore risking ovulation and pregnancy.
Your best source of information for drug recalls is either the FDAor the manufacturer who, by law, are coordinating on the recall.
Here is the FDA release FDA and the Pfizer one. Pfizer statesthat they believe there are about 30 affected packages:
IMHO - and note, IANAD - any package that has the correct count of the correct coloured tablets in the correct order is safe to take and is unlikely to cause an increased pregnancy risk.
The affected lots would only be those packaged on the same line/under the same timeframe/same circumstances as the problem lots. Considering how redundant documentation/labelling/equipment use tracking is, there is no reason to think that there are any at-risk lots not listed in the recall. This is not something that affects birth control pills in general.There is no reason to doubt the safety of other products not listed in the recall.
The reason for concern was the phrasing “and generic.” Low-Orgestrel is a generic of Lo/Ovral 28. Turns out they meant “generic, manufactured by Pfizer” which is indeed what I was 99% sure it meant, but I prefer to be 100% sure and a quick review of lot numbers resolved that.
Ah, I see - I didn’t bother to verify if it was the same generic drug: you were right to clarify, particularly for others who might stumble across this thread.
I assume that the packages are not serialized beyond lot number? There was a question about if all the packages in a lot were bad - from what I read, the answer is no, but there is no way of subsetting lots.
I don’t do drugs but I do do electronic components, and expensive parts like processors are individually serialized while inexpensive parts like capacitors are only lot serialized.
I was glad to find that I had a visit from good old Aunt Flow last night. I tried calling Akrimax to verify that my next 2 pill packs are okay as long as the colors look correct - they already had a menu option for people calling with questions about the recall. Then I was played a recorded greeting asking me to leave a message because they were busy with other callers. Haven’t heard back yet.
No, they are not serialized beyond the lot number; it’s incredibly impractical given the sheer size of a drug lot, particularly with mixed dosing like in birth control. A single lot can make hundreds of packages of pills. For high-volume stuff like birth control pills, a new lot might be manufactured every couple of days, so a recall might only involve a month’s worth of production (note that’s a WAG…I don’t actually know in the case of this particular recall).
Since Pfizer stated that they suspect that only 30 or so packages are actually affected, I suspect the error was a machine/equipment set-up or employee training one. If I understand correctly, placebo pills are accidentally being packaged in the spots for the active pills. I will WAG that either the machines were incorrectly installed in such a way that placebos are getting caught in them and being spit out at random, or that an employee (or group of employees) are incorrectly transitioning from one piece of equipment to another, resulting in some mixup of the drug batch (perhaps not verifying if a chute is clear of one type of pill before tossing the other type into a hopper, something like that). This would affect a few packages, but not all packages in a run, and it’s possible that the random sampling done for QC purposes simply didn’t grab an affected package. In theory this would be caught as part of the quality control ID testing to release the drug for shipment, but something so infrequent and random can slip through, since only a random, statistically significant portion of packages are individually verified. It’s just not possible to examine each and every package.
That’s why the recall is so extensive - they might have identified the cause, such as [whenever X worked/happened/got changed] and then pored through their records to find which lots were being packaged at the time of X, and voluntarily recalled all of them to see the extent of the issue. Pfizer will be looking at/recording the problem packages, so if you have one, you should contact the manufacturer/Pfizer and let them know. I’m inclined to believe them when they say that the issue has been identified and corrected - the FDA will have verified this as well, and you can be assured that the manufacturing plant will be audited again soon to ensure that whatever new procedures have been implemented are being followed.
