Misbranding product recall (expiration date)

[stm08007]

I have been getting more involved in Regulatory matters, and one thing that I would like to confirm my understanding on is related to recalls for misbranded product.

In a past (large) company I worked for, there was an issue where a small batch of products (~3 units) had an incorrect expiration by 1 month. Per procedure, it was allowed a 5 year shelf life, however the label was fat-fingered. The product in question is custom-built, used quickly, and the particular batch was ordered under the "rapid manufacturing" option to get it to the customer that week. The product was built for a pediatric patient, and in 5 years they would surely be a larger size anyways. I remember the product went through quite a few Regulatory folks and different decisions were made. There was a time when the path was "there are mitigating factors and we can confidently justify that this product will not be used past its expiration date", and there was a time when the path was "this is a black and white issue- the product is misbranded and there's no amount of justification in the world that would avoid a recall".

My question is, is misbranded product like this black and white or can justification ever be made to leave the product on the market? I'm also thinking of a situation where there's a mixed lot noted in inventory where there's 1% of product noted to have its expiration off by a week. Do you need to recall everything in the field because it *might* be off by a week? Or is it more of a risk based decision where you can assess what are the chances that the product is actually mislabelled and what are the effects of that (if in the above situation, maybe there's a 0.00000000001% the product would even be used 5 years later-- does that count for anything?).

 

[ChrisM]

My first thought is.... if your internal analysis is that the product will be safe until the incorrect expiry date, why not raise a Concession to document this issue and avoid a recall? you can mention that a recall has been considered and deemed unnecessary on the concession.

 

[stm08007]

My first thought is.... if your internal analysis is that the product will be safe until the incorrect expiry date, why not raise a Concession to document this issue and avoid a recall? you can mention that a recall has been considered and deemed unnecessary on the concession.

I understand your point but that's not exactly what I'm saying:
1) can you argue that there is realistically no chance that the product will be used after what *should be* the correct expiration date? (as an example-- imagine you are making custom pediatric mouth guards, and you just happen to test them and label them with a 20 year shelf life... you accidentally put 20 years and a week on the label and you have no evidence to support that extra week. But realistically, your product is designed to be used in 1 year; nobody is using a custom product they grow out of 20 years later, etc).

2) Going a step further on number one, what if you don't have definitive proof that the label issue affected what is in the field, but there is a 10% chance that it does. Do you need to recall based on the potential? Or are you able to do risk based decision making and look at what is the risk of the product in the field leading to harm, etc

 

[Ed Panek]

First conduct a risk based assessment on the error. Regulatory action of recall also has risk in the device wont be meeting its intended purpose for hundreds? of patients while the recall is ongoing. If the risk is not related directly to the essential performance of the device it might be justifiable.

I would consider a CAPA though to prevent future risks.

 

[stm08007]

First conduct a risk based assessment on the error. Regulatory action of recall also has risk in the device wont be meeting its intended purpose for hundreds? of patients while the recall is ongoing. If the risk is not related directly to the essential performance of the device it might be justifiable.

I would consider a CAPA though to prevent future risks.

thank you, this is the answer I was looking for. so you are saying that "misbranding" is not a black and white automatic recall. A scenario could exist where the risk of not recalling is negligible/less of a risk than taking product off the market.

 

[Nichole F]

Be sure to also carefully review your shelf life studies. Many times the shelf life is rolled back by a percentage to provide a safety buffer. For example, your shelf life on your provided example may be labelled as 5 years but your shelf life validation study may show the product is actually fit for use 5 years and 2 months. This can cover anticipated misuse where a user may use the product that shows it is expired because it only recently expired. It doesn't sound like the latter would apply to your product.

Also consider what the risks are of using product beyond its stated shelf life. The more reasoning you can document as to why this situation will not present a risk to users, the better chance you have of justifying why a recall was not initiated. As Ed mentioned, be sure to include the risk of users not having access to the recalled products.

 

[Ed Panek]

Be sure to also carefully review your shelf life studies. Many times the shelf life is rolled back by a percentage to provide a safety buffer. For example, your shelf life on your provided example may be labelled as 5 years but your shelf life validation study may show the product is actually fit for use 5 years and 2 months. This can cover anticipated misuse where a user may use the product that shows it is expired because it only recently expired. It doesn't sound like the latter would apply to your product.

Also consider what the risks are of using product beyond its stated shelf life. The more reasoning you can document as to why this situation will not present a risk to users, the better chance you have of justifying why a recall was not initiated. As Ed mentioned, be sure to include the risk of users not having access to the recalled products.

We tested our shelf life beyond what we claim just to have a safety measure in place. If needed we could justify N+1 years of shelf life

We didn't update our claims or labelling because

It would influence customer buying and stocking decisions. While we encourage bulk purchases a customer with 5 years of product in their warehouse also creates a risk. Customers purchase large product inventories, causing our sales $ to fluctuate, causing layoffs, etc.

It requires us to update our labels

It is a "bullet" we keep in our back pocket in case a customer needs N+1 years of shelf life we can provide it to them.

The requirement is you have testing (accelerated and then real) of shelf life. You can claim any shelf life in that window. Thats a business decision at that point.

 

[stm08007]

Be sure to also carefully review your shelf life studies. Many times the shelf life is rolled back by a percentage to provide a safety buffer. For example, your shelf life on your provided example may be labelled as 5 years but your shelf life validation study may show the product is actually fit for use 5 years and 2 months. This can cover anticipated misuse where a user may use the product that shows it is expired because it only recently expired. It doesn't sound like the latter would apply to your product.

Also consider what the risks are of using product beyond its stated shelf life. The more reasoning you can document as to why this situation will not present a risk to users, the better chance you have of justifying why a recall was not initiated. As Ed mentioned, be sure to include the risk of users not having access to the recalled products.

yes thank you! We do indeed have a slight buffer, so I am not too too worried about this particular issue; these are more hypothetical questions so I am more confident dealing with potential future issues that may come up. The risk of "no access" is a good consideration to remember as well!

 

[stm08007]

We tested our shelf life beyond what we claim just to have a safety measure in place. If needed we could justify N+1 years of shelf life

We didn't update our claims or labelling because

It would influence customer buying and stocking decisions. While we encourage bulk purchases a customer with 5 years of product in their warehouse also creates a risk. Customers purchase large product inventories, causing our sales $ to fluctuate, causing layoffs, etc.

It requires us to update our labels

It is a "bullet" we keep in our back pocket in case a customer needs N+1 years of shelf life we can provide it to them.

The requirement is you have testing (accelerated and then real) of shelf life. You can claim any shelf life in that window. Thats a business decision at that point.

yep, all that makes sense and seems easy to justify if you have the aging studies to support the label going against your released procedures. I was more asking if you didnt have that aging data to support the mislabeling whether you could EVER justify it as a non-recall, but I got my answer so thank you again!