Rabies Immunoglobulin Recall EL(26)A/18: What Procurement Teams Need to Know

What Has Been Recalled and Why

Bio Products Laboratory Limited (BPL), a UK-based plasma products manufacturer, has issued a Class 2 recall of a single batch of Human Rabies Immunoglobulin (HRIG) 500IU solution for injection. The recall reference is EL(26)A/18.

The reason for the recall is a stability failure affecting this specific batch. Testing has shown a reduction in the potency of the Human Rabies Immunoglobulin below the required specification. A reduction in potency in a rabies post-exposure prophylaxis product is a clinically significant finding, as the efficacy of the product in preventing rabies infection following potential exposure depends directly on delivering an adequate dose of neutralising antibody.

What a Class 2 Recall Means

The MHRA classifies medicines recalls into three categories based on the potential risk to patients. A Class 2 recall indicates that the product may cause temporary or medically reversible adverse health consequences, or that the probability of serious harm is considered remote but cannot be excluded.

In practice, a Class 2 recall still requires immediate action. Healthcare providers holding the affected batch must quarantine the stock, stop using it, and follow the return or destruction instructions provided by the manufacturer. Continuing to use a recalled batch, even under a Class 2 designation, is not appropriate and carries regulatory and clinical risk.

For a product like Human Rabies Immunoglobulin, where the recall reason is reduced potency, the concern is that a patient receiving post-exposure prophylaxis with the affected batch may not receive sufficient neutralising antibody to reliably prevent rabies infection. Given that rabies is almost always fatal once clinical symptoms develop, any uncertainty about the efficacy of post-exposure treatment is clinically unacceptable.

Who Is Affected

This recall affects any hospital, pharmacy, travel health clinic, or occupational health service holding stock of the specific recalled batch. Human Rabies Immunoglobulin is used in post-exposure prophylaxis (PEP) for individuals with potential rabies exposure, typically following animal bites or scratches in endemic regions. It is not a routinely stocked product in every hospital, but it is held by travel health clinics, infectious disease units, and hospitals that serve populations with travel exposure risk.

If your institution holds Human Rabies Immunoglobulin from Bio Products Laboratory and is uncertain whether the stock is from the recalled batch, cross-reference your batch documentation against the recall reference EL(26)A/18 and contact BPL directly for confirmation.

Immediate Steps for Pharmacy and Procurement Teams

If your institution is affected by this recall, the following steps should be taken promptly:

1. Quarantine affected stock immediately. Remove the recalled batch from active stock and place it in a clearly labelled quarantine area. Do not dispense or administer.
2. Check for any recent administration. Review dispensing records for the recalled batch. If the product has been administered to patients recently, assess clinical risk in line with current rabies PEP guidelines and seek clinical advice as needed.
3. Follow the recall return instructions. Contact Bio Products Laboratory for return and credit arrangements in line with their recall notice.
4. Assess your remaining supply. Determine whether your institution has adequate unaffected HRIG stock to cover any anticipated need. If stock is insufficient, begin sourcing an alternative immediately.
5. Notify clinical teams. Ensure infectious disease, travel health, and emergency medicine teams are aware of the supply situation so they can plan accordingly.

Sourcing Alternative Human Rabies Immunoglobulin

Human Rabies Immunoglobulin is produced by a limited number of manufacturers globally. With one BPL batch now recalled, institutions that depended on that stock will need to identify an alternative source quickly.

Alternative HRIG products are available from manufacturers in other markets. These can be sourced through an MHRA-licensed pharmaceutical wholesaler under the UK's unlicensed medicines framework, specifically under the named patient supply route provided for in Regulation 167 of the Human Medicines Regulations 2012. This is the same legal mechanism used for other shortage and unlicensed medicine situations.

The supply requires a registered prescriber to initiate the request for a specific patient, and the product must be supplied through a Wholesale Dealer Authorisation (WDA) holder licensed by the MHRA.

Euro Biom holds the relevant MHRA WDA and operates specifically in shortage, recall, and urgent supply scenarios. We have established supplier relationships across international markets and can source HRIG with appropriate documentation for UK importation. In patient-critical situations, we can typically arrange sourcing and dispatch within 24 to 72 hours of receiving a confirmed requirement.