Introduction
The primary goal of a food recall is to protect public health by removing products from
commerce that have been determined to be unsafe. A recall plan can aid in the
execution of a recall by apportioning duties, centralizing current contact information, and
providing prewritten templates for communications. Key Individuals that will be
participating in a company recall should review the recall plan and be familiar with the
execution of the plan.
Definitions
· 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.
· Depth of Recall: The level of product distribution for the recall (consumer, retail,
institutional, wholesale).
· Distribution List - A product specific distribution list which identifies accounts that
received the recalled product. Requested information includes type of business,
account name, addresses, and contact information.
· FDB – California Department of Public Health, Food and Drug Branch
· Market Withdrawal - A firm's removal or correction of a distributed product which
involves a minor violation that would not be subject to legal action by the regulatory
agency or which involves no violation, e.g., normal stock rotation practices, routine
equipment adjustments and repairs, etc.
· Press Release - A notice that alerts the public (including regulators, retailers,
consignees, other distributors, processors, and consumers) that a product presents a
serious hazard to health. Not all recalls require a press release; the regulatory agency
will advise the firm when a press release is necessary.
· Recall - A firm's removal or correction of a marketed product that the regulatory
agency considers to be in violation of the laws it administers and against which the
agency would initiate legal action, e.g., seizure. Recall does not include a market
withdrawal or a stock recovery.
· Recall Committee – The group comprised of key staff with the expertise, authority,
and responsibility to manage the recall.
· Recall Plan - A written contingency plan for use in initiating and implementing a recall
in accordance with 21 CFR Sec. 7.40 through 7.49, 7.53, and 7.55. The Recall Plan
should be reviewed annually and revised as necessary when personnel, procedures,
processes, suppliers, or as other factors change.
· Recall Strategy - A planned specific course of action to be taken in conducting a
specific recall, which addresses the depth and scope of recall, need for public
warnings, and extent of effectiveness checks for the recall.
· Scope of Recall: Defines the amount and kind of product in question.
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