The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Class 4 Medicines Defect Notification concerning specific batches of benzylpenicillin benzathine, an injectable antibiotic used in the UK. The alert follows notification from Brancaster Pharma Limited that two batches, 72500105 and 72500107, were distributed with an outdated patient information leaflet (PIL).
Affected Batches and Details
The affected medicine has an expiration date of October 31, 2029, and was first distributed on June 26, 2026. The MHRA stated that the PIL included in these cartons was the previous version revised in April 2023, instead of the latest approved PIL dated November 2025.
Nature of the Update
The update pertains solely to the section intended for healthcare professionals, specifically subsection “Special precautions for disposal and other handling,” reflecting changes to section 6.6 of the Summary of Product Characteristics (SPC). Additional information was added regarding the potential for benzylpenicillin benzathine formulations to block the needle if intramuscular injection is not administered at a slow, steady rate, along with practical guidance to mitigate this issue.
Impact on Patients and Healthcare Professionals
The MHRA emphasised that the quality of the powder for suspension for injection is unaffected. The missing information relates only to updated instructions for healthcare professionals on preparation and administration. Healthcare professionals have been informed and should take these details into account when reconstituting and administering the products. Patients do not need to take any action, but those experiencing adverse reactions should seek medical attention and report via the MHRA Yellow Card scheme.
Corrective Actions
Brancaster Pharma Limited will provide hard copies of the updated PIL to wholesalers and pharmacies upon request via enquiries@brancasterpharma.com. All future batches will include the correct PIL. The notification applies only to the listed batches.
