Product recall Class II

Class II recall is the 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. It is preventative in nature and issued if there is no immediate danger of death or other serious injury linked to the product.

Examples of Class II recalls include
*Botulinum potential and Norovirus contamination in seafood
*The presence of undeclared dry milk as an ingredient in sausage,
*A food that contains yeast or mold contamination
*Candy with FD&C #5 yellow dye not listed on the label
*Metal shavings in a canned food.

FDA recall classifications are designed to help companies identify and resolve product defects before they cause additional, unnecessary harm consumers. Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority.
Product recall Class II

Product recall Class I

Recalls are an effective method for removing or correcting marketed products, their labeling, and/or promotional literature that violate the laws administered by the Food and Drug Administration (FDA).

The FDA recall classifications range from Class I (most severe) to Class II (moderately severe) and Class III (least severe).

Class I recall is the situation in which there is reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequence or death.

Examples: Product tampering or mislabeling of a lifesaving drug; foods that are found to contain the toxin causing botulism, foods contaminated with very pathogenic pathogens (including but not limited to Listeria monocytogenes, Salmonella or pathogenic E. coli); or a food that contains one of the eight (the Big‐8) common allergens but is not properly labeled to indicate the presence of these allergens.
Product recall Class I

Recalls requested by regulatory agency

Recall is an action taken to withdraw/remove the drugs from distribution or use including corrective action for which deficiencies are reported in quality, efficacy or safety. The defective products related to quality includes Not of Standard Quality, Adulterated or Spurious drugs.

A recall occurs when a firm removes or corrects a marketed product that violates FDA-administered laws and regulations and would be subject to FDA legal action.

All food firms should have a recall plan in place, in order to act promptly and effectively in the event of a recall. Being prepared reduces the risk of potentially harmful or hazardous food from reaching consumers and potentially wreaking devastating effects on human health and the economy.

There are basically three types of recall policies
· Voluntary recalls
· Product seizures
· Recalls may be requested by the regulatory agencies due to the product being harmful, a risk to the public, or out of compliance with food regulations.

Firms may initiate a recall following notification of a problem by FDA or a state agency, in response to a formal request by FDA, or as ordered by FDA.

FDA also has mandatory recall authority for a variety of products, including FDA-regulated devices, certain biological products and food.

A firm should promptly consult with technical experts and legal counsel if FDA requests or recommends a recall. It should also ask FDA questions in areas such as the scientific and public health basis for the recall; the scope of the recall (including areas of distribution, dates of manufacture and types of products).

FDA may take appropriate regulatory action or other measures when the firm fails to recall violative product or when a recall action fails.
Recalls requested by regulatory agency

Voluntary product recalls

A food recall is a firm’s voluntary removal of distributed food products from commerce when there is a reason to believe that such products are adulterated or misbranded under the provisions of applicable state and federal laws. Recall does not include a market withdrawal or a stock recovery.

Voluntary recalls are the most common method of effectively removing or correcting consumer products in violation of FDA and USDA regulations.

A voluntary recall occurs when the company decides to pull the product from the stream of commerce because of a safety issue. Unsafe food is food that may cause illness or physical harm to a person who consumes it because, for example, it contains pathogenic microorganisms or physical hazards. By law, businesses are legally required to do this or risk paying fines or having their operations shut down entirely.

A firm should initiate a voluntary recall by promptly sending recall communications to each affected direct account, and by issuing a press release or other public notice, if appropriate. FDA considers the date of a firm’s first communication about a recall, either to its direct accounts or to the public, to constitute the date of initiation.
Voluntary product recalls

Main reason for product recall

A product recall is a formal request by a firm to its consumers, to discontinue the use of a product as it was sold or produced.

The purpose of product recall is to ensure that systems are in place to limit liability for corporate negligence, which can cause costly legal penalties and to improve or avoid damage to publicity.

A decision to recall a food can be triggered by a number of situations. A recall is often initiated by a food business operator on the basis of their knowledge, or because they have reason to believe that a food is unsafe.

Most food items are recalled are due to manufacturing fault. Food recalls mainly as a result microbiological contamination (arising from bacteria, viruses, or parasites), which causes brief illness, severe sickness, or death, with the most severe effects expected among older, very young, or immune compromised consumers.

Peanut contamination in 2008, was one of the largest food recalls in US history, triggered by salmonella fears. The company responsible, Peanut Corporation of America, filed for bankruptcy.
Main reason for product recall

Food product recall strategy

Recall may be undertaken voluntarily and at any time by manufacturer and distributors or at the request of the FDA.

Recall is generally more appropriate and affords better protection for consumers than seizure, when many lots of product have been widely distributed.

A recall strategy will address the following elements regarding the conduct of the recall:
*Depth of recall
The depth of recall is the distribution chain levels at which the recall will be aimed. If a product is not hazardous, a recall aimed only at wholesale purchases may suffice.

*Public warning
If the public health is seriously jeopardized, the recall may be designed to reach the individual consumer, often through a press release.

*Effectiveness checks
The purpose of effectiveness checks is to verify that all consignees at the recall depth specified by the strategy have received notification about the recall and have taken appropriate action.
Food product recall strategy

Product Recall: Policy and Classification

Product Recall: Policy and Classification
Recall Policy
There are basically three types of recall policies

• Voluntary recalls are the most common method of effectively removing or correcting consumer products in violation of FDA and USDA regulations.

• Recalls may be requested by the regulatory agencies due to the product being harmful, a risk to the public, or out of compliance with food regulations.

• Product seizures occur when manufacturers refuse to recall a product or when the recall is ineffective and the violation continues.

Recall Classification

• Class I recall is the situation in which there is reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequence or death.

• Class II recall is the 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 is the situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.

Product Recall: Policy and Classification