OIT-008 · Incident, recall and reassessment
Reaction, suspected deviation or change involving an allergen batch.
Template for local scientific review and approval. This is not an approved SOP of a specific laboratory.
OIT-008 · 1.0 · 10.09.2026
Scope
Reaction, suspected deviation or change involving an allergen batch.
Roles and prerequisites
Responsible pharmacist: approves implementation and release. Trained operator: performs and records work. Reviewer: verifies critical items. Specialist clinician/analytical partner: as specified.
Before implementation complete local document IDs, named roles, suitable equipment, specific specifications and acceptance criteria. Check the applicable framework in your country.
Procedure
In an acute reaction, the clinical emergency plan and appropriate emergency services take priority. The laboratory does not provide an alternative treatment protocol.
Record product, lot, container, reported intake, timing and available information with privacy protection. Do not automatically assign causality.
Suspend supply of the suspect batch and notify the responsible pharmacist and clinical team. Check shared raw materials and adjacent work for contamination.
Preserve samples and data. Examine identity, calculation, mixing, recovery, labelling, dosing device and transport/use conditions.
Organise recall and reporting to competent bodies where required. Record contacts and reconcile affected quantities.
Close with documented investigation, CAPA and effectiveness review. Restarting or changing dose is the specialist’s decision, separate from technical correction of a batch.
Stop criterion
Do not resume supply of a suspect product before the required assessment is complete.
Related records
Sources
- EAACI — Guidelines on the management of IgE-mediated food allergy
- FDA — PALFORZIA: product information and package insert
- NAPRA — Model Standards for Pharmacy Compounding of Non-sterile Preparations (2018; clarification 2022)
These sources inform the original editorial synthesis. Their publishers do not adopt or endorse this SOP.
Local approval
Local version: __________ Effective date: __________
Author: __________ Reviewer: __________ Pharmacist approval: __________
Signatures / dates: __________ Next review: __________