Incident, recall and reassessment

Procedure

1. In an acute reaction, the clinical emergency plan and appropriate emergency services take priority. The laboratory does not provide an alternative treatment protocol.
2. Record product, lot, container, reported intake, timing and available information with privacy protection. Do not automatically assign causality.
3. Suspend supply of the suspect batch and notify the responsible pharmacist and clinical team. Check shared raw materials and adjacent work for contamination.
4. Preserve samples and data. Examine identity, calculation, mixing, recovery, labelling, dosing device and transport/use conditions.
5. Organise recall and reporting to competent bodies where required. Record contacts and reconcile affected quantities.
6. Close with documented investigation, CAPA and effectiveness review. Restarting or changing dose is the specialist’s decision, separate from technical correction of a batch.

Edition-specific detail

Investigation distinguishes an expected clinical reaction from identity, dose, contamination or product errors. A negative retained-sample result does not exclude a problem in another withdrawal. Preserve the device, label and available remainder with secure traceability; clinical cofactors are assessed through the responsible specialist.

Related forms

F-007, F-010