6 replies to this topic

[zechzplz]

Under what circumstances would I contact or not contact the FDA regarding a recall? For example, let’s say one of our suppliers issues a voluntary recall on an item they supplied us. The item was then distributed to a customer. Would we then initiate a voluntary recall if it’s just for that one company? If the product was fully recovered, did not reach the masses, and/or was not in large quantities (does not require public notification), would we need to contact FDA?

 

I guess I have this idea that recalls are super serious and notification should be reserved for class 1 and 2 levels… but for those who did have recalls, no matter the reason or level, how did you respond and handle it? I am editing our recall document and I want to get as much information as possible and to consider all the scenarios! 

[it_rains_inside]

I would say you need to re-think about the purpose of a re-call. When you say "super-serious" ...they all are!! Really anything that is considered for a recall is going to be serious to someone. Either to the person potentially being affected by whatever is wrong with the product, or by the company's image of a poor quality product hitting the market.

 

Whatever the reason - a company is not going to recall a product just "because". There has to be some serious implications. The FDA does a nice job of outlining classes and what is involved in each one - see below... If you are interesting in how others have handled it - there are some nice threads on this site about others who have gone through them and what they did.. I'll try and track down one.. but here are the recall classes with a little summary of the levels. 

 

 

The Food and Drug Administration (FDA) requires all food companies to have a written recall program in case any products need to be recalled.  This procedure outlines the condition under which a recall will be initiated, delegate’s responsibility for implementing the various steps of the procedure, and specifies the necessary steps to be taken in the event withdrawal of our product from the marketplace is required.

 

II. CLASSIFICATION OF RECALLS                                                                                             

1.CLASS I RECALLS - Involves a clear and immediate danger to health.  There is a reasonable probability that the product may cause illness or death, requires recall to the consumer level, individual consumer notification, and 100% effectiveness checks.

 

2.CLASS II RECALLS - Involve products that, though they could pose a threat to health and safety under certain circumstances, are not regarded as immediate hazard.  This usually requires recall to the retail level, possible public warning and some level of effectiveness checks.

 

3.CLASS III RECALLS - Involves products that are relatively safe in consumer's hands, but which violate some specific regulation and are thus legally required to be removed from the marketplace.  Such a recall could involve recall to the wholesale level, no public notification, and no effectiveness checks.

 

DEFINITIONS

Serious Container Hazard - Safety-related problem due to faulty packaging materials.

 

Market Withdrawal - Quality failure with no safety or regulatory hazard and product is only suspect (not classified as a recall by the FDA).

 

Stock Recovery - Can be any of the classifications of recall, but the stock was not released for distribution.

[it_rains_inside]

Actually I hate to do this...

 

But if you just search the word recall or recalls there are a myriad of threads on this subject, by searching the titles maybe you can find some of the info you are looking for.

 

Cheers and Good Luck 

[Snookie]

Why is the product being recalled?  You need to recall the product from your customer whether or not you have to notify the public or FDA. 

[shea quay]

This sounds similar to the European system of recall / withdrawal. A recall is a serious issue that must be communicated to the public, and followed up by a thorough investigation by the food safety and quality team. A withdrawal is a largely sales based exercise that is much less damaging to the brand and the company. You need to notify the relative authorities of a recall, but only need to record in a management meeting a withdrawal. As Snookie says, it depends on the seriousness of the issue. As I would say, it also depends on the possible damage to the brand you are producing. 

[trubertq]

Recall =  business to consumer ( it's coming off the shelves of the supermarket)

Withdrawal = business to business, it's not on the shelves yet.

 

You must ( in Ireland and with the SFPA) inform statutory bodies and your CB of a recall. You don't need to inform about a withdrawal. Remember the statutory bodies are there to HELP you get all your product back so work with them makes life easier for everyone.

[teaks]

Under what circumstances would I contact or not contact the FDA regarding a recall? For example, let’s say one of our suppliers issues a voluntary recall on an item they supplied us. The item was then distributed to a customer. Would we then initiate a voluntary recall if it’s just for that one company?

 

I would say, too, that you need to check with the supplier as to whether it notified the FDA.  If your supplier notified the FDA, you are going to hear from them, so you should be proactive and notify them first. But have your strategy ready before notifying them.