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OIT-008 / 2.1

Incident, recall and reassessment

Reaction, suspected deviation or change involving an allergen batch.

Collection and scientific editing: Stasinos Chr. SikaliasContent edition: 2.1Record editorial review date: 2026-10-14

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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.

Additional 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.

When extending the investigation record shared raw material, premix or vehicle and all linked batches. Technical release of a replacement batch does not authorise treatment restart.

Stop criterion

Do not resume supply of a suspect product before the required assessment is complete.

Related forms

F-007, F-010

Sources and references

  1. EMA — Guideline on Allergen Products: Production and Quality IssuesEMEA/CHMP/BWP/304831/2007; adopted 20 November 2008; effective 20 May 2009; remains current effective quality version on EMASections 2, 4.1.1, 4.2.4.4, 4.4.3–4.4.5; document pp. 4–13Industrial biological-allergen quality guidance; principles adapted explicitly, not a compounding authorisation or a food-OIT recipe2026-10-14
  2. Santos AF et al. EAACI guidelines on the management of IgE-mediated food allergyAllergy. 2025;80:14–36; online 2024Recommendations 8, 9, 12 and 13; desensitisation versus remission/continued treatmentSpecialist clinical recommendations; not stability evidence for local syrups or suspensions2026-10-14
  3. FDA — PALFORZIA prescribing informationUS prescribing information, Revised 07/2024; rechecked 2026-10-14Sections 2.3, 4, 5, 11 and 16; current FDA-linked labelSpecific authorised product only; no equivalence with pharmacy-made peanut preparations2026-10-14
  4. NAPRA — Guidance Document for Pharmacy Compounding of Non-sterile PreparationsMarch 2018, clarification January 2022Sections 5, 6 and 7; master/batch records, delivery, qualityQuality-system implementation; historical BUD table not substituted for 2022 USP revision2026-10-14
  5. EMA — Guideline on allergen products development for immunotherapy and allergy diagnosis in moderate to low-sized study populationsEMA/161669/2025; adopted 10 June 2025; effective 1 January 2026Sections 2, 4 and 4.1 (Type I allergy quality aspects); pp. 4–6; section 8.4 for food-allergy endpointsIndustrial allergen development and quality guidance; complements 2008 guideline. Section 4.2 Type IV patch-test exceptions are not transferred to food OIT.2026-10-14