Product Recalls

What is a Product Recall?

A product recall is a request that a batch or an entire production run of a product be returned to the manufacturer, usually due to the discovery of safety issues. The recall is an effort to limit liability for corporate negligence (which can cause costly legal penalties) and to curb bad publicity. Recalls are costly to a company because they often entail replacing the recalled product or paying for damages caused in use.

A country's consumer protection laws will have specific requirements in regards to product recalls. Safety-related recalls can be voluntarily initiated by the manufacturer, or made compulsory by a government agency if the risk is seen to be significant and if it is in the best interests of the consumer.

Where to learn about product recalls?

Being aware of product recalls is important for the safety of anyone who comes in contact with the product. Recalls are not always easy to learn about, and companies do not always publicize a recall in an effort to limit the cost of replacing the product.

Common Sources of Recall Information

* Grocery Stores (listings)

* Mailings

* News (television/print)

* Internet

Steps required to recall a product.

A product recall usually involves the following steps, which may differ according to local laws:

* Company/Supplier notifies the respective government agency of their intention to recall a product. Consumer hotlines or other communication channels are established.

* Product recall announcements are released on the respective government agency's website (if applicable), as well as in paid notices in the metropolitan daily newspapers. In some circumstances, heightened publicity will also result in news television reports advising of the recall.

* Typically, the consumer is advised to return the goods, regardless of condition, to the store from which it was purchased for a full refund or modification.

* Avenues for possible consumer compensation will vary depending on the specific laws governing consumer trade protection.

List of dangerous drugs.

Some drugs have been withdrawn from the market subsequently to their introduction due to risks for the patients. Usually this has been due to unexpected adverse effects that were not detected during Phase III clinical trials and were only apparent from post-marketing surveillance data from the wider patient community.

* thalidomide (1950s-1960s) - withdrawn due to risk of teratogenicity; returned to market as an anti-neoplastic drug under FDA orphan drug rules

* diethylstilbestrol (1970s) - withdrawn due to risk of teratogenicity

* phenformin and buformin - withdrawn due to risk of lactic acidosis

* ticrynafen (1982) - withdrawn due to risk of hepatitis

* methaqualone (1984) - withdrawn due to risk of addiction and overdose.

* triazolam (1991) - withdrawn in the United Kingdom due to risk of psychiatric adverse drug reactions

* Fen-phen - popular combination of fenfluramine and phentermine; phentermine remains on the market, dexfenfluramine & fenfluramine (1997) later withdrawn

* lysergic acid diethylamide (LSD) (1950s-1960s), marketed as a psychiatric cure-all; withdrawn after it became widely used recreationally by hippies

* terfenadine (1998) - withdrawn due to risk of cardiac arrhythmias; superseded by fexofenadine

* mibefradil (1998) - withdrawn due to dangerous interactions with other drugs

* troglitazone (2000) - withdrawn due to risk of hepatotoxicity; superseded by pioglitazone and rosiglitazone

* alosetron (2000) - withdrawn due to risk of fatal complications of constipation; reintroduced 2002 on a restricted basis

* cisapride (2000s) - withdrawn in many countries due to risk of cardiac arrhythmias

* cerivastatin (2001) - withdrawn due to risk of rhabdomyolysis

* rapacuronium (2001) - withdrawn in many countries due to risk of fatal bronchospasm

* rofecoxib (Bextra) (2004) - withdrawn due to risk of myocardial infarction

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