Guidance required on whether to recall or withdraw.

Hi,

Can anyone help on what guidance is required in the Recall Procedure for decision making on whether the event constitutes either a withdrawal or a recall?

Many thanks.

Hi,

Can anyone help on what guidance is required in the Recall Procedure for decision making on whether the event constitutes either a withdrawal or a recall?

Many thanks.

From the FDA:

Recalls are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority.

• Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
• Class II recall: a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
• Class III recall: a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
• Market withdrawal: occurs when a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal.

Hi,

Can anyone help on what guidance is required in the Recall Procedure for decision making on whether the event constitutes either a withdrawal or a recall?

Many thanks.

Dear terrine1,

I assume Scotland's Food legislation is same as for England, ie as per FSA? (or in this case equally derived from EC Regulations).

If so, I think this query has previously been discussed here before. From memory, the option "basically" depends on whether or not the (retail?) product has already been distributed to direct customer access or not ?

A relevant FSA guidance document is probably -
fsa1782002guidance.pdf   84.79KB   51 downloads

• 'Withdrawal' is the process by which a product is removed from the
supply chain, with the exception of product that is in the possession
of consumers.

•'Recall' means the process by which a product is removed from the
supply chain and where consumers are advised to take appropriate
action, for example to return or destroy food.

Other actions may also be involved (eg see Article 19)

and also http://www.food.gov....rcement/alerts/

No doubt other UK posters here can correct me if above not appropriate.

Rgds / Charles.C