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Service area · Wholesale distribution of medicinal products

Control medicine returns, recalls and suspected falsification

Last updated: 27 August 2026

GDP processes for returned medicines, saleable-stock decisions, batch recalls, mock recalls, quarantine and suspected falsified medicines.

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GDP returns · medicine recall · falsification

Returns, recalls and falsification protection in pharmaceutical wholesale

GDP processes for returned medicines, saleable-stock decisions, batch recalls, mock recalls, quarantine and suspected falsified medicines.

Time-critical quality events need predefined decisions, traceable data and clear communication. We connect SOPs, ERP/WMS status and Responsible Person governance.

Expert-reviewed by Martin Didunyk · licensed pharmacist · 27 August 2026

tiger.PHARMA Expertise

Topics we master

Assess returned medicines

Returns remain quarantined until origin, timing, conditions, integrity and traceability have been assessed.

Physical and system quarantine
Capture customer, product and batch data
Assess storage and transport conditions
Document release, destruction or return

Medicine recall and mock recall

The plan defines roles, availability, data sources, customer messages and authority escalation.

24/7 escalation contacts
Generate batch and customer lists
Track quantities and responses
Exercise speed and completeness

Suspected falsification

Suspect stock is immediately segregated and blocked while the defined investigation and notification route is activated.

Recognise product and supply-chain warning signs
Block warehouse and ERP status
Engage the RP immediately
Coordinate authority and supply-chain communication

Data, quarantine and communication

Recall capability relies on consistent product, batch, serial and movement data.

Clear stock status codes
Controlled securPharm exception handling
Approved message templates
Audit-ready decision record

FAQ

Frequently asked questions

When may a returned medicine re-enter saleable stock?

Only when the defined GDP criteria are met, storage and transport remain demonstrably acceptable, the pack is intact and an authorised decision is documented.

What is a mock recall?

A planned exercise testing whether affected batches, recipients and quantities can be identified completely within the target time and communication routes work.

What happens when falsification is suspected?

The product is immediately segregated and blocked from distribution, with the Responsible Person and required external parties engaged through the approved escalation route.