United States
Hong KongHandling a recall
The procedure is to identify affected stock by lot number, quarantine it, follow the recall notice, and document. The recall class indicates urgency.
A procedural question rather than a knowledge one, and the procedure is short.
The steps
- Read the notice and identify exactly what is affected, by product and lot number
- Search stock, including anywhere the product might be held outside the main shelf
- Quarantine what you find, physically separated and clearly marked
- Follow the notice - return, destroy or hold as instructed
- Document what was found, what was done and when
- Address patients who received affected product, where the notice requires it
The lot number is what identifies it
A recall names a product and specific batches. The NDC says what the product is; the lot number says which manufacturing run.
A recall of a product without reference to lot is unusual, and pulling everything when only certain lots are affected is a different error from pulling nothing.
Product left on the shelf with an intention not to dispense it will eventually be dispensed by someone who did not get the message. Separation and marking are the control, and they take a minute.
The class sets the urgency
Class I means a reasonable probability of serious adverse health consequences or death. Class II means temporary or reversible consequences, or a remote probability of serious ones. Class III means harm is not likely. All three are defined at 21 CFR 7.3.
A Class I recall is acted on immediately and usually involves contacting patients. A Class III may not.
Documentation is the deliverable
A recall response that was performed and not recorded cannot be demonstrated. The record is what shows the pharmacy acted.
Related terms
A market withdrawal involves a minor violation not subject to FDA legal action, or no violation. A stock recovery concerns product that never left the manufacturer's control.
Common questions
What is the recall procedure in a pharmacy?
Identify affected stock by lot, quarantine it, follow the notice, and document.
What identifies affected product?
The lot number. The NDC says what the product is; the lot says which run.
What does quarantine mean?
Physically separated and clearly marked, not merely noted.
How does the class affect the response?
It sets urgency. Class I means possible serious harm or death and is acted on immediately.
Why document?
A response that was performed and not recorded cannot be demonstrated.