Hi,
Could somebody help me find a link for the guidelines when to have a product recall or withdrawal?
Currently, we are into BRC accreditation and clause 3.11.2 at a minimum requires for it.
In advance, Thank you for those who will reply to this topic.
Hi Jannel,
The FDA has specific definitions of market withdrawal and recall. If you export to the US, you may be under FDA jurisdiction; however, I'm not sure if the guidelines globally are different.
A recall (there are three classes) would be the removal or correction of a product in commerce that the FDA considers being in violation of its laws.
- Class 1 Recall: Reasonable probability that the use or exposure to product will cause serious health consequences or death.
- Class 2 Recall: Use or exposure to product may cause temporary or medically reversible health consequences or probability of serious adverse health consequences is remote.
- Class 3 Recall: Use or exposure to product is not likely to cause health consequences.
A market withdrawal is the removal or correction of a product in distribution, which involves only a minor violation, which would not be subject to FDA action. An example of this would be the removal of old stock from distribution channels.
Basically, if the affected product has some likelihood to cause health consequences (be it physical, biological, chemical, radiological), it would be considered a recall. The definitions can be found on the link below.
http://www.fda.gov/S...s/ucm165546.htm
QAGB