Drug Recalls: How Pharmacy Technicians Handle Them

What Is a Drug Recall?

A drug recall occurs when a product is removed from the market because it is defective, contaminated, mislabeled, or potentially harmful. Most recalls are initiated voluntarily by the manufacturer, though the FDA can mandate a recall if necessary. Pharmacy technicians play an essential role in identifying, removing, and documenting recalled products.

FDA Recall Classifications

Class I - Most serious. Reasonable probability that use of the product will cause serious adverse health consequences or death. Example: a contaminated injectable.
Class II - May cause temporary or medically reversible adverse effects. The probability of serious harm is remote. Example: a mislabeled product with incorrect strength.
Class III - Not likely to cause adverse health consequences. Example: a product with a minor labeling error that does not affect use.

The Recall Process in the Pharmacy

When a recall notice arrives, the pharmacy follows a standard process:

Check inventory for the recalled lot numbers or NDC codes
Remove affected products from shelves and quarantine them
Document the quantity removed and lot numbers
Follow the manufacturer's instructions for return or destruction
Notify patients who received the recalled product if required
Update the pharmacy management system to prevent further dispensing

Identifying Affected Products

Recalls are product-specific, identified by NDC number and lot number. A recall of one lot does not mean all lots are affected. Technicians must carefully match the recall notice to inventory. Wholesalers and the FDA Enforcement Reports are key sources for recall information.

Patient Notification

For Class I recalls, pharmacies typically contact patients directly to advise them to stop using the product and return it. For Class II and III, the approach depends on the specific risk and pharmacy policy.

Recall questions appear regularly on the PTCE. Practice identifying recall classes with PTCB flashcards to prepare for exam day.