FDA Drug Recall Classifications
FDA drug recall classifications are a three-tier system (Class I, II, and III) that categorizes product recalls based on the severity of the health hazard posed by the defective or potentially harmful product.
Exam Tip
Class I = most serious (death possible). Class II = temporary/reversible. Class III = unlikely to harm. Know the recall workflow: identify, quarantine, document, return. Lot numbers identify recalled products.
What Are FDA Recall Classifications?
The FDA classifies drug recalls into three classes based on the relative degree of health hazard posed by the product. Recalls can be initiated voluntarily by the manufacturer or mandated by the FDA. Pharmacy technicians must understand recall classes to respond appropriately when a recalled product is identified in inventory.
Recall Class Definitions
| Class | Severity | Health Risk | Example |
|---|---|---|---|
| Class I | Most serious | Reasonable probability of serious adverse health consequences or death | Contaminated injectable, wrong drug in packaging, lethal dosage error |
| Class II | Moderate | May cause temporary or medically reversible adverse health effects; probability of serious consequences is remote | Underdeclared allergen, subpotent drug, labeling error |
| Class III | Least serious | Not likely to cause adverse health consequences | Minor labeling errors, wrong color capsule, packaging defects |
Recall Process
| Step | Action |
|---|---|
| 1. Notification | FDA issues recall notice with product details, lot numbers, and class |
| 2. Identification | Pharmacy checks inventory for recalled lot numbers |
| 3. Quarantine | Affected products are immediately removed from dispensing stock |
| 4. Documentation | Record the quantity of recalled product on hand |
| 5. Return | Follow manufacturer/wholesaler instructions for product return |
| 6. Patient notification | For Class I recalls, pharmacy may need to contact patients who received the product |
Market Withdrawal vs. Recall
| Action | Description |
|---|---|
| Recall | FDA-classified action to remove a defective product from the market |
| Market Withdrawal | Manufacturer removes a product for a minor issue that would not be subject to FDA action |
| Safety Alert | FDA communication about a potential safety issue |
MedWatch and Recall Resources
| Resource | Purpose |
|---|---|
| FDA MedWatch | Adverse event and safety reporting system |
| FDA Recall Database | Searchable database of current recalls |
| Drug wholesaler alerts | Direct notifications from suppliers |
| State BOP | State-specific recall response requirements |
Pharmacy Technician Responsibilities
- Monitor recall notifications daily
- Check lot numbers against current inventory
- Immediately quarantine recalled products
- Notify the pharmacist-in-charge
- Document all actions taken
- Assist with patient notification if required (Class I)
Exam Alert
Drug recalls are tested in the Dispensing Process domain of the ExCPT. Know the three classes (I = most serious/death possible, III = least serious), the recall response steps, and that lot numbers are the key identifier for recalled products.
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Related Terms
Lot Number
A lot number is a unique identifier assigned by a drug manufacturer to a specific batch of medication produced at the same time and under the same conditions, used for tracking, quality control, and recall purposes.
NDC Number (National Drug Code)
The NDC (National Drug Code) is a unique 10-digit, 3-segment numeric identifier assigned to each medication product in the United States, identifying the labeler, product, and package size.
Controlled Substance Schedules
Controlled substance schedules are the DEA's five-tier classification system (Schedule I through Schedule V) that categorizes drugs based on their accepted medical use, abuse potential, and likelihood of causing dependence.
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