Glossary: Recalls and Alerts
By Mary Anne Dunkin
Use this quick guide to understand types of recalls and alerts that may affect medication or devices needed for arthritis treatments.
What is a recall?
Where Recalls Occur
- Consumer-level recall: Includes individual patients, physicians and hospitals and may require action on the part of the consumer, such as returning for a medication to the pharmacy for a refund or calling a special hotline number for more information.
- Retail-level recalls: Directed at retailers and providers.
- Wholesale-level recalls: Involves distribution between the manufacturer and retailer.
Three Classes of Recalls
- Class I: The most serious, class I recalls are issued when there is a defect with a drug – due to contamination of raw materials, for example – or labeling that could lead to serious health problems or even death.
- Class II: Class II recalls are issued when exposure to the drug may cause a temporary or medically reversible health problem or a slight chance of a serious problem.
- Class III: Class III recalls are issued for products that violate FDA regulations – for example, a bottle that doesn’t contain the number of pills stated on the label – but are unlikely to cause adverse health consequences.
Types of Medical Alerts
Medical device safety alert: An alert issued by the manufacturer of a medical device that presents a risk of substantial harm. These are sometimes considered recalls.
Black box warning: Also called a “boxed warning,” this an alert the FDA may require manufacturers to place on a medication label or package insert if medical studies suggest the drug carries a significant risk of serious or life-threatening adverse events.
Drug shortage: Defined by the FDA as a situation in which the total supply of all clinically interchangeable versions of an FDA-regulated drug is inadequate to meet the current or projected demand at the patient level.
- Recalls.gov – www.recalls.gov
- MedWatch; The FDA Safety Information and Adverse Event Reporting Program – www.fda.gov/MedWatch/report.htm, 800/332-1088
- FDA Recalls, Market Withdrawals, and Safety Alerts – www.fda.gov/Safety/Recalls/default.htm
- FDA Enforcement Reports – www.fda.gov/Safety/Recalls/EnforcementReports/default.htm
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