My HPRA: Register

Carrying out Recall and Related Actions on the Irish Market

The MAH should propose whether or not any market action is required. Agreement should be reached with the HPRA on the required market actions.  All recall communications resulting from a quality defect should be approved by the HPRA prior to issuance. Based on the classification of the defect and other factors, such as the distribution of the affected batch(es), one or more of the following market actions may be required.

1. Batch or Product Recall

Three classes of recall exist

  • Class I (equivalent to a critical classification)
  • Class II (equivalent to a major classification)
  • Class III (equivalent to a minor classification)

Depending on the classification, a recall will progress to different levels, requiring different timelines and communication lines. Recalls are usually notified by printed letter, but may also be carried out by phone and email, depending on the severity or urgency of the defect issue.

Patient / User level

Typically Class I, patient level recalls involve rapid communication methods. Email and telephone communications may be used to contact healthcare professionals and patients to facilitate retrieval of affected packs. In order to reach as high a percentage of patients as possible, it may be necessary to release website and / or press statements.

Retail / Pharmacy Level

More commonly, batches are recalled to retail level, which includes pharmacies, hospitals, clinics, convenience stores (for general sales products), licensed merchants and veterinary surgeons. The majority of retail level recalls are Class II.

Wholesale Level

Where the risk is deemed low (usually Class III) a wholesale level recall may be sufficient. Where more than one wholesaler is involved, a recall letter is required. If stock is being recalled from the primary wholesaler only, no formal communication is required. 

Blanket and Targeted Recalls

A key part of preparation for a recall is a consolidated listing of customers, to which the affected batch(es) was distributed. The listing may extend to:

  • Retail customers supplied by the primary wholesaler
  • Secondary wholesalers supplied by the primary wholesaler
  • Retail customers supplied by the secondary wholesalers

If it is possible to compile such a listing in a timely manner, a targeted recall can be carried out. This means that only those customers supplied with the affected batch(es) will receive a recall letter. If a targeted listing cannot be achieved (for large recalls with multiple wholesalers) then a blanket recall communication is sent.

Blanket communications are directed to all wholesalers and all retailers in Ireland. Blanket recall letters to pharmacies are sent with the aid of the Pharmaceutical Society of Ireland, who can provide mailing labels for all registered pharmacies upon request and after agreement with us. Urgent blanket recall notification can be emailed to all registered pharmacists in Ireland by the QDR section.

2. Caution-In-Use-Notifications

In certain cases, it will not be possible or warranted to carry out a batch or product recall. An alternative action is to issue a Caution-In-Use Notification (CIUN). A CIUN may be used to provide information to healthcare professionals when:

  • The product is critical in nature and cannot be recalled
  • Clarification is needed on incorrect or missing product information

Monitoring of recall actions and communications

After recall letters/caution in use notifications have been issued, monitoring should be carried out by the MAH to ensure that the communications have successfully reached their targets and the directions are being followed. Monitoring should include spot checks and reconciliation of returned packs.

To be properly prepared for a recall, a company should have at their disposal the following:

  • Full, consolidated listing of customers which have received the affected batch(es)
  • Where appropriate, confirmation or otherwise that unaffected batches are available for replacement of the recalled packs. The need for replacement stock should be considered as part of the risk assessment
  • Draft wholesale/retail/patient recall letters. The HPRA requires a standard letter to be prepared, available in our Recall Guidance Note. The letter must be approved by the HPRA prior to sending
  • Helplines set up to respond to medical and/or commercial queries which arise during the recall. Staff manning those lines should have sufficient knowledge of the recall and defect issue to deal with the queries. Out of hours contacts should also be available

Further details on preparing for and carrying out recalls are available in our Recall Guidance Note.

Root Cause Analysis and CAPAs

The QDR section, as well as coordinating market actions resulting from quality defects, aids in the investigation of those defects, to ensure the requisite actions are carried out; to correct the defect issue and to prevent recurrence. A company should endeavour to identify a root cause(s) for each defect issue. Accurate identification of root cause(s) will allow implementation of appropriate and necessary Corrective and Preventative Actions (CAPAs). The majority of defect cases require confirmation of CAPAs, before they can be closed.

Root causes and CAPAs should be detailed inthe investigation report requested by the QDR group.  If a recall has taken place this will form part of the recall report.