Class II Sterile Product Shelf Life Labeling - Should we do a recall?



Hoping for opinions on this scenario:
this is for US jurisdiction, FDA. No sales Outside USA.
A class II, sterile product that we acquired was labeled for 2 years shelf life. the previous company (510k) owner did a shelf life study to extend the product to 5 years shelf life. Upon acquisition, we began relabeling product that was already built with 5 years shelf life - the correct expiration date is this coming july.
During a recent random review of finished goods, we found that 1 batch was mis labeled as if it had a 6 year shelf life (i.e. instead of label reading it would expire this coming july, it is now labeled to expire the following july.)
Normally this would be a case-closed recall, but here is our thought. Firstly, there is an obvious internal CAPA for the break down in procedure/process that allowed this to happen. and then there is a Health Hazard Analysis. We've written the analysis and it could say that, 'of course, in July of this year, there is a risk to the population (potentially breached barrier or non-usable material) however, before July, the product is not a risk. We've since begun accelerated age testing and in May of this year we will have an answer for 6 year shelf life. If the testing passes, the mislabeled product is good, if it fails, we must recall.' and of course, this would happen prior to the july 2015 date. Curious to know people's reaction to this strategy. Would FDA take a hard stance that the product should have been recalled right away....or because we took action to investigate, prior to any risks to humans, our actions were acceptable.
thanks for thoughts.
Elsmar Forum Sponsor


Re: Class II sterile product Shelf Life - Should we do a recall?

I understand your argument for waiting...but I don't think FDA would buy it. You (inadvertently) distributed product that was mislabeled at the time of distribution according to the information then available to you. Ergo, a field action is required for that batch.

That normally would be a recall for various reasons, but in theory it could be a correction i.e. relabeling in the field, if the batch is small enough and you know where it all is, and the economics justify.

TWA - not the airline

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Another thought: How fast does your product typically turn over in the field? Maybe this lot has long since been used up. If you could confirm this beforehand with the customers that did receive product from this specific lot, then IMHO there is no recall/field action. If you send the "Dear doctor" letter first and then find out that there is nothing left to recall, then the damage is done...
As an afterthought: How sure are you that this is a singular event? Did you check the copies of the labeling in your DHRs?


Thanks miregmar and TWA.
I appreciate your opinions. There is certainly work to be done on the CAPA side to verify that this is indeed a one-off situation and further, to improve our systems and processes so this does not happen again.

Just to pressure test your opinions and see if they change - The issue has been detected after selling product to about 10 customers over the course of about 5 months. (a slow moving product). The issue was detected as we were selling the last units from this batch, and therefore, this issue was not instantly was detected quite some time after release of the the misdeed of distributing mislabeled product has occurred no matter how you slice it. So, the product was violative yesterday, and the day before, and the day before etc. We've put our arms around the issue with the preliminary action of quarantining current product, have aged product coming out in May, and have high confidence that the testing will pass with flying colors (very simple product configuration). Where the scope of customers/product in field is so small, a FSCA would take just a short time to execute (1 month or less) and therefore risk is even further mitigated in the slim chance we would have to perform the FSCA. i haven't found any regulation that specifies when the timing of a FSCA must be executed...only the circumstances which trigger an FSCA. In the circumstance where a product is mislabeled with the wrong diameter, it wold be text book, but here, this label has the potential to be corrected without field action.
Still believe a recall right now is required? thanks
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