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How To Identify Recalled Products

Within the FDA’s charter and website, the FDA had launched a guidance document intended to provide information on how to fulfill the FDA’s plans regarding recalled products.  It is worth noting that this document had first been introduced and published in November of 2003, however with the applicability of this document still being relevant today, there have been very little revisions in terms of what it is that this guidance document was based upon.  We’ll convey to the reading audience of Bad Drug the main points and the general understanding of how it is that the FDA fulfills its obligations to the public to ensure that recalled products are immediately taken off the market.

In tandem with its own guidelines and those propositioned on the behalf of the federal government, the FDA has set up a system to inform the public about recalls, whether they have been voluntarily recalled by the company manufacturing the product or whether it has been done at the behest of the FDA and jointly undertaken with the company.  The guidelines set up by the FDA provides specific recommendations and is applicable to both mandatory or voluntary recalls of all products regulated by the FDA, such as food (animal feed, infant formulas, etc.), drugs, radiological and medical devices, cosmetics, human biological products including blood and even human tissue.

According to the agency’s guidelines, the spirit of cooperation among distributors and manufacturers who expedite recall activities is vital in the way the agency operates, because when a determination is made that a product is potentially hazardous to the general public and animals or is in violation of the Federal Food, Drug and Cosmetic Act, the agency is obliged to act swiftly to maintain all protocols and this undertaking demands the utmost attention and care.  The firms who undertake the recalls are strongly urged to notify their local FDA District Recall Coordinator as soon as a decision is made regarding whether a recall is appropriate under the circumstances.  This should be done prior to the issuance of written or press notifications to customers.

The FDA encourages anyone in the general public to contact their local recall coordinator when the possibility of a recall occurs.  Furthermore, it is recommended that someone who is submitting information to the FDA to not wait to submit this information until ALL applicable information is prepared correctly and given to the FDA prior to notification.  This early submission gives the agency the opportunity to review and comment upon the written notification and then the FDA chooses to offer guidance and assistance to the recall process.

Under a special set of circumstances, the FDA has set up with the federal government a website that dispenses to the public the appropriate information to give them the opportunity to see if a product that they’re contemplating about taking might be compromised or not.