From Pharmacy Drug Guide
A drug recall is initiated when a product is temporarily or permanently removed from the market. Recalls may occur because a product has been determined to be potentially harmful or is defective. Sometimes problems are discovered by the product's manufacturer and a recall is initiated by the company. Other times, the Food and Drug Administration, or FDA, may raise concerns about a product, prompting a recall.
Often, recalls stem from new or worse side effects than those discovered or reported during a drug's initial clinical research. This may happen after "fast track" FDA approvals, which the FDA sometimes grants drugs that treat serious diseases.
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Types of Drug Recalls
There are five distinct FDA actions that may be referred to as recalls. The government agency only firmly defines the first three as actual recalls; the fourth is not a true recall, and the fifth may be a recall in some situations, but this is not always the case.
- Class I recall: This type of recall occurs when there is reasonable evidence that a drug can cause major harm to users or others who may be exposed to it. In some cases, the drug may even cause death.
- Class II recall: This type of recall involves drugs that are shown to harm the health of users or those exposed to it in ways that are temporary or may be treated. These risks are less serious than in a Class I recall, and there is little risk of major harm or death.
- Class III recall: Class III recalls are not likely to cause any health problems, either serious or minor.
- Market withdrawal: Market withdrawals are the work of companies, and happen when the product defect is not serious enough to worry the FDA. In these cases, the manufacturer either stops selling the product or corrects the issue.
- Medical device safety alert: This category, which may or may not include a recall, applies to medical devices that pose a health risk to users.
In most cases, stores offer refund policies for recalled drugs. However, the FDA recommends that consumers check with their doctors before acting on any reports of a drug recall.
FDA Drug Recall Records
A record of all Drug Class I, II, and III recalls can be found in the FDA Enforcement Report. Recalls that have not yet been classified are also included in the Report, which is released every Wednesday. Unclassified recalls can been found under the heading "Recalls Pending Classification: Drugs."
Serious adverse events, product quality problems, product use errors, or therapeutic inequivalence/failures that may be associated with use of a drug, biologic, medical device, dietary supplement or cosmetic may be reported to the FDA at 800-332-1088.
The FDA has jurisdiction over recalls involving:
- medications and other drugs
- prosthetics and medical devices
- other biologics
- blood and plasma products
- veterinary products
Drug Side Effects
Pages in category "Drug Recalls"
The following 21 pages are in this category, out of 21 total.