FAQs: PRODUCT RECALL INFORMATION

flash · 04-16-2007, 03:46:34 PM

PRODUCT RECALL INFORMATION

Please post all information on product recalls in this (Consumer Reviews and Product Recalls) forum.

If you are the first to post information on a recall, please include

The specific product or brand information
An official link (www.fda.gov, manufacturers� web site, etc.) or other information with the details of the product recall

Frequently Asked Questions about Product Recalls

What is a Product Recall?
A product recall includes any �corrective action by a company needed to protect consumers from potentially adverse effects of a product�.

Why are Products Recalled?
Product recalls typically involve products that may be unsafe, contaminated, or mislabeled, do not conform to manufacturer�s specifications, or are missing allergen or other hazard warnings, or that have been adulterated or tampered with in some way.

All product recalls are voluntary actions by the responsible corporation. Their goal in recalling a product is to get unsafe and/or defective products out of consumer hands as quickly as possible.

From a manufacturer�s point of view, the recall should:
locate all defective products as quickly as possible;
remove defective products from the market and from consumers; and
communicate information about the problems and remedies quickly and effectively.

Specific recall actions depend upon the danger, where and how the product was marketed, who uses it, the estimated shelf life, etc. A recall will also take in to account a manufacturer�s own policies, ethical understanding, regulatory requirements, and financial constraints.

What is a Voluntary Recall?
All product recalls are voluntary, and the decision to recall a product is made by the company management.

If the company does not initiate a recall, the responsible government agency may request that the company do so. The government has limited authority, however. If a company did refuse to recall a product, the government agencies have legal authority to seize available (unsold) product, stop operations, and initiate a court request for a product recall. The government cannot recall a product or require customers be reimbursed.

Why does a company voluntarily recall a product?
Recalling the product allows the company to destroy, replace, and/or alter the problem product. In addition to protecting consumer health, the company must demonstrate they have corrected the problem and are complying with existing rules and regulations. The company also needs to minimize the cost of the recall, while regaining and improving the company�s reputation for future sales and business.

Who pays for the Recall?
The manufacturer/company is responsible for all of the costs involved in this process. Most companies carry product recall insurance to assist with the costs of the recall.

Can I get my money back?
All recalls are voluntary, and the terms are determined by each company when a recall is announced. In general, a company will refund the suggested retail value of the recalled item(s).

Refunds may be for the suggested retail price, product exchange (damaged product is replaced with a new product without charge), or voucher (coupon for a free product that replaces the damaged product).

Are receipts required for a refund?
Recalls are based on returning a defective product to the manufacturer, and not the actual purchase. Receipts are generally not accepted, unless returns are made directly to the store at which it was purchased.

Manufacturers generally require the actual product to be returned (and tested or destroyed by their facility). Receipts are not generally required, since it is not the purchase that is being confirmed, but the product retrieved.

Proof of possession (i.e., confirmation that you have the recalled product) is usually required. This usually requires the entire product be returned, including any unused portion. This assists the company in determining or confirming which products, lot numbers, production lines, etc., had problems, the extent of the problem, confirming that the problem has been isolated and any hazard removed and destroyed�and also helps the company protect against fraudulent claims.

How many can I return?
In general, all items recalled may be returned for full refund or exchange.

However, since all recalls are voluntary, the company issuing the recall may choose to evaluate �unusual� returns on a case by case basis, according to the actual distribution of the product, �resonableness�, and their own financial constraints.

Why the does Company/Manufacturer Need all that Information?
The goal of any product recall is to retrieve, repair, or replace products already purchased or on the shelves. Maintaining accurate records about each product is essential for a company to conduct an effective, economical product recall.

Generally, the following records are key both to identifying product defects and conducting recalls:

Records of complaints, warranty returns, insurance claims, and lawsuits.
Production records: lot numbers and product codes associated with each run, the volume of units manufactured, component parts or substitutes use, and other pertinent information which will help the company identify defective products or components quickly.
Distribution records: location of each product by product line, production run, quantity shipped or sold, dates of delivery, and destinations.
Quality control records.
Product registration cards.

Role of Government Agencies
What is FDA's role in a recall?
FDA has no authority to order a recall. FDA does monitor the progress of a recall and perform audit checks at wholesale or retail customers to verify the recall's effectiveness.

FDA FAQs (www.fda.gov):

The Frequently Asked Questions (FAQs) below, as well as others reached through the links on the right, cover basic and timely information and guidance for those interested in the many products FDA regulates and other agency responsibilities. Answers usually include further links to in-depth information included throughout FDA's Web site, as well as on the sites of other government agencies.

What does FDA do?
FDA ensures that the food we eat is safe and wholesome, that the cosmetics we use won't harm us, and that medicines, medical devices, and radiation-emitting consumer products such as microwave ovens are safe and effective. FDA also oversees feed and drugs for pets and farm animals. Authorized by Congress to enforce the Federal Food, Drug, and Cosmetic Act and several other public health laws, the agency monitors the manufacture, import, transport, storage, and sale of $1 trillion worth of goods annually, at a cost to taxpayers of about $3 a person. More about FDA.

What should I do if I have a food or drug product that has been recalled?
If you have a recalled medical product, talk to your health professional about the best course of action. For other products, take it back to the place of purchase and ask for a refund. Stores generally have a return and refund policy when a company has announced a recall of its products.

What does FDA do with defective products?
Products found to be unfit for consumers are withdrawn from the marketplace, either by voluntary recall or by court-ordered seizure. These products usually are destroyed, or in some cases, they are reconditioned to be in compliance with FDA regulations. Recent recalls.

Is there an FDA food safety hotline?
For general food safety questions, call the FDA Food Safety Hotline at 1-888-723-3366. If the situation is critical, phone FDA's emergency number, 301-443-1240, which is staffed 24 hours a day. If your questions involve meat or poultry products, call the U.S. Department of Agriculture's hotline at 800-535-4555. More on food safety can be found at www.foodsafety.gov.

Does FDA control pesticides in foods?
The Environmental Protection Agency regulates the sale and use of pesticides. But FDA regularly tests foods to determine if pesticides are present in unacceptable amounts. If elevated levels are found, FDA takes corrective action.

Does FDA regulate illegal drugs?
Controlling the illegal use of "street" drugs such as heroin, cocaine and marijuana is the job of the federal Drug Enforcement Administration (DEA). However, if a street drug were to be studied for legitimate medical uses, FDA would regulate it as an investigational drug. FDA-regulated prescription drugs such as barbiturates and amphetamines are sometimes abused and wind up as street drugs. These cases then fall into DEA's jurisdiction.

What should I do if I've had an adverse reaction to an over-the-counter or prescription medicine?
Contact your doctor right away and urge him or her to report the problem to the FDA MedWatch hotline, 800-FDA-1088 or online at https://www.accessdata.fda.gov/scripts/medwatch. Your doctor, however, is not required to report to FDA. Therefore, consumers can report problems directly. For more information, visit the MedWatch Website.

Other information:
http://ohioline.osu.edu/aex-fact/0251.html

FDA recall summary page:
http://www.fda.gov/opacom/7alerts.html

Product recall info for manufacturers
http://www.cpsc.gov/businfo/corrective.html