Hibiwash 500ml Recall EL(26)A/15: Microbial Contamination Found at Manufacturing Facility

What Has Been Recalled and Why

Regent Medical Limited, acting for Molnlycke Health Care, has issued a Class 2 recall of specific batches of Hibiwash 500ml. The recall reference is EL(26)A/15. The trigger for the recall was routine weekly microbiological monitoring at the manufacturing facility, which identified microbial contamination. This is an important finding because Hibiwash is an antiseptic skin wash, classified as a medical device or medicinal product depending on its precise formulation and intended use, and its very purpose is to reduce microbial load on skin.

Hibiwash contains chlorhexidine gluconate 4% w/v as its active ingredient. Chlorhexidine is a broad-spectrum antiseptic with activity against bacteria, fungi, and some viruses. Finding microbial contamination at the manufacturing facility during the production of a chlorhexidine-based product is a significant quality event that warrants a Class 2 recall to remove affected batches from the supply chain.

Why Contamination in an Antiseptic Product Is Clinically Significant

The intended use of an antiseptic skin wash is to remove or kill microorganisms on the skin surface. In surgical and high-risk clinical settings, this forms part of the infection prevention chain. If the antiseptic product used for pre-operative skin preparation or surgical hand scrubbing is itself microbially contaminated, it could introduce organisms onto the very areas being prepared for surgery or invasive procedures.

Hibiwash is used in operating theatres, ICUs, and other clinical environments where patients are often immunocompromised, have indwelling devices, or are undergoing procedures that break the skin barrier. In these contexts, even a low level of microbial contamination in an antiseptic product carries meaningful clinical risk, which explains the Class 2 designation.

Hospital infection control and pharmacy teams should treat this recall with appropriate urgency. Checking whether the affected batch numbers are present in the clinical environment, particularly in operating theatres and procedure rooms, should be a priority action.

Steps for Hospital Pharmacy and Procurement Teams

1. Obtain the batch numbers listed in the EL(26)A/15 recall notice and check against your stock in all clinical areas, particularly theatres, ICUs, and procedural suites.
2. Quarantine all affected batches immediately and remove from clinical use.
3. Notify infection control and theatre teams of the recall so they can verify their locally held stock.
4. Source alternative chlorhexidine skin wash from unaffected batches or alternative suppliers to maintain continuity of antiseptic preparation in clinical areas.
5. Follow Regent Medical's return instructions and document the recall response for your organisation's governance records.