(Manoj Singh) #1

1 Recall operations should be capable of being initiated promptly and at any time.
2 All Competent Authorities of all countries to which products may have been distributed
should be informed promptly if products are intended to be recalled because they are, or
are suspected of being defective.
3 The distribution records should be readily available to the person(s) responsible for
recalls, and should contain sufficient information on wholesalers and directly supplied
customers (with addresses, phone and/or fax numbers inside and outside working hours,
batches and amounts delivered), including those for exported products and medical
4 Recalled products should be identified and stored separately in a secure area while
awaiting a decision on their fate.
5 The progress of the recall process should be recorded and a final report issued,
including a reconciliation between the delivered and recovered quantities of the
6 The effectiveness of the arrangements for recalls should be evaluated regularly.

(Md.Asif Hussain) #2

How we can retrieve the distributed product upto consumer level? and what will be further action…

(Manoj Singh) #3

The Food, Drug & Cosmetics Act administered by the Food and Drug Administration (FDA) classifies recalls into three classes:

Class I: Involves a life-threatening situation. FDA will mandate a consumer recall, a 100 percent effectiveness check and appropriate public announcements.

Class II: Involves a potentially hazardous situation, but not a life-threatening condition. FDA will usually mandate a recall to the retail outlets and will not require a 100 percent effectiveness check. A press release may be required, depending on the reasons for the recall.

Class III:Involves no serious hazard. It is usually limited to the wholesale level with no effectiveness checks and no press release requirements.

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