The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Class 4 Medicines Defect Notification regarding an injectable form of penicillin used across the UK. Brancaster Pharma Limited notified the MHRA that certain batches of benzylpenicillin benzathine were distributed with an outdated patient information leaflet (PIL).
Affected Batches and Details
The affected medication carries batch numbers 72500105 and 72500107, with an expiry date of October 31, 2029. These batches were first distributed on June 26, 2026. The MHRA stated that the PIL in the cartons contained the previous version revised in April 2023, instead of the latest approved PIL dated November 2025.
Nature of the Defect
The update was limited to the section intended for healthcare professionals, specifically subsection 'Special precautions for disposal and other handling', reflecting an update to section 6.6 of the Summary of Product Characteristics (SPC). Additional information was added regarding the potential for benzylpenicillin benzathine formulations to block in the needle if intramuscular injection is not made at a slow, steady rate, and practical guidance to mitigate this issue.
Impact on Healthcare Professionals
Healthcare professionals have been furnished with the correct information. The MHRA advised: 'Healthcare professionals should read the details in this notification and take this into account when reconstituting and administering these products.' Brancaster Pharma Limited will provide hard copies of the updated PIL to wholesalers and pharmacies upon request via enquiries@brancasterpharma.com.
Patient Guidance
The MHRA emphasized that the quality of the powder for suspension for injection is not affected. The missing information relates only to instructions for healthcare professionals, which have already been provided. Patients are not required to take any action but should seek medical attention if they experience adverse reactions, which should also be reported via the MHRA Yellow Card scheme.
