Handling Product Recalls Print

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When stock must be withdrawn.

WHAT A RECALL IS

An instruction to remove a product or batch from supply.

WHO ISSUES THEM

The medicines regulator, or the manufacturer.

WHY THEY MATTER

Affected product causes harm, and failure to act is a serious finding.

WHAT TO ESTABLISH

How recall notices reach you.

WHAT SOURCES EXIST

Regulator communications and publications Supplier and manufacturer notifications Professional body communications

WHAT TO DO ON RECEIVING ONE

Identify whether you hold the product and batch Quarantine it immediately Stop supply Establish whether any was dispensed Follow the instructions given Record everything

WHY BATCH RECORDS MATTER SO MUCH

Without them, you cannot establish what you hold or what you supplied.

WHAT TO DO ABOUT DISPENSED PRODUCT

Follow the guidance, which may require contacting patients.

WHAT THAT REQUIRES

Dispensing records identifying who received which batch.

WHAT TO ESTABLISH

Whether your records can answer that question.

WHY ASK NOW

The answer determines whether you could comply.

WHAT TO RECORD FOR EACH RECALL

The notice What you held What action was taken What was returned or destroyed Confirmation to the issuer, where required

WHAT TO KEEP

The complete record.

WHY

Inspectors examine recall handling.

WHAT TO REVIEW

Whether the process worked, afterwards.


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