Fda recall letter template 2025

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Class III - a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
A recall notice must identify the firm conducting the recall by stating the firms legal name and commonly known trade name, and the city and state of its headquarters. The notice must state whether the recalling firm is a manufacturer (including importer), retailer, or distributor. (h) Identification of manufacturers.
Recall notices Make sure your customers are not in danger by giving: a clear description of the product to be recalled, including model numbers. details of the problem. a statement describing the hazard.
Any batch of a product not meeting the defined quality standards has to be recalled from the market. Recall can be of two types; Voluntary Recall and Statutory Recall.
This recall has been initiated due to [describe problem and how it was discovered]. [Use/Consumption] of this product may [describe any potential health hazard]. This product was shipped between [range of distribution dates] or This product was shipped to you on [date].
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People also ask

While both the FDA and USDA have their own definitions of product recall classes, they follow the same general rule 1= most serious / dangerous, 2= potentially dangerous and 3 = least dangerous.

recall notice template