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.
Exam Tip
Lot numbers identify specific manufacturing batches for recalls and tracking. Use FIFO inventory method. Know the three recall classes (I = most serious, III = least serious) for the ExCPT.
What Is a Lot Number?
A lot number (also called a batch number) is an alphanumeric code assigned by the manufacturer to a specific production batch of a drug product. Every unit produced in that batch shares the same lot number, making it possible to trace the medication back to its manufacturing conditions.
Why Lot Numbers Matter
| Purpose | Description |
|---|---|
| Recall tracking | Identifies exactly which units to pull from shelves during a recall |
| Quality control | Links to specific manufacturing records (equipment, raw materials, personnel) |
| Expiration dating | Each lot has its own expiration date based on stability testing |
| Adverse event investigation | Helps FDA trace problems to specific batches |
| Inventory management | First-in, first-out (FIFO) inventory control |
Where to Find the Lot Number
| Location | Description |
|---|---|
| Stock bottle label | Printed on the manufacturer's label |
| Unit dose packaging | On each individual blister pack or unit |
| Box/carton | On outer packaging |
| Prescription label | Required in some states; best practice to include |
Lot Numbers and Drug Recalls
| Recall Class | Severity | Lot Number Role |
|---|---|---|
| Class I | Serious health risk or death | Lot number used for urgent identification and removal |
| Class II | Temporary or reversible health risk | Lot number used for targeted product removal |
| Class III | Unlikely to cause adverse health effects | Lot number used for inventory reconciliation |
Pharmacy Technician Responsibilities
- Record lot numbers when receiving inventory
- Check lot numbers against recall notifications
- Use FIFO (first-in, first-out) to dispense oldest lot first
- Remove recalled lot numbers from stock immediately
- Document any recalled products returned to the manufacturer
Exam Alert
Lot numbers appear in the Dispensing Process domain. Know that lot numbers are essential for drug recalls, that pharmacy technicians must check recall notifications against inventory, and understand the three FDA recall classes.
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Related Terms
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.
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.
Beyond-Use Dating (BUD)
Beyond-use dating (BUD) is the date after which a compounded preparation should not be used, determined by the pharmacy based on USP standards and the stability characteristics of the specific formulation.
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