The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a 'Class 4 Medicines Defect Notification' for certain batches of benzylpenicillin benzathine, an injectable penicillin antibiotic distributed in the UK. Brancaster Pharma Limited notified the MHRA that two batches, 72500105 and 72500107, with an expiry date of October 31, 2029, were released with an outdated patient information leaflet (PIL). The initial distribution occurred on June 26, 2026.
Details of the Defect
The MHRA stated that the affected packs contain the previous PIL revised in April 2023, while the latest approved version dates from November 2025. 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 the needle if intramuscular injection is not administered at a slow, steady rate, along with practical guidance for healthcare professionals to mitigate this issue. The notification relates only to the listed batches; all future batches will include the correct PIL.
Impact on Healthcare Professionals and Patients
Healthcare professionals have received the accurate information and should take the details 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 at enquiries@brancasterpharma.com.
For patients, the MHRA advised: 'The quality of the powder for suspension for injection is not affected by this issue. The information missing from the Patient Information Leaflet relates only to updated instructions for healthcare professionals on the preparation and administration of the injection. These products are prepared and administered by healthcare professionals and the missing information has been provided to them. No further action is required for the patient.'
Patients who experience adverse reactions or have questions should seek medical attention and report suspected reactions via the MHRA Yellow Card scheme.
