New UK antibiotics alert as 'defect' notice issued

New UK antibiotics alert as 'defect' notice issued The MHRA has issued a Class 4 Medicines Defect Notification for certain batches A new warning has been issued for a type of penicillin used across the UK. The Medicines and Healthcare products Regulatory Agency (MHRA) announced in a new 'Class 4 Medicines Defect Notification' that Brancaster Pharma Limited had notified it that certain batches of benzylpenicillin benzathine - an injectable antibiotic - were distributed with an out-of-date patient information leaflet (PIL). The affected medication has two batch numbers, 72500105 and 72500107, an expiry date of October 31, 2029, and was initially distributed on June 26, 2026. The MHRA said: "Brancaster Pharma Limited has informed the MHRA that the Patient Information Leaflet (PIL) in the cartons for the batches listed in this notification were released with an outdated PIL. These packs contain the previous PIL that was revised in April 2023. The latest approved PIL is dated November 2025. "The update was limited to the information intended for healthcare professionals only section, subsection "Special precautions for disposal and other handling", and reflects an update to section 6.6 of the Summary of Product Characteristics (SPC). "Additional information was added regarding (1) the potential for benzylpenicillin benzathine formulations to block in the needle if intramuscular injection of the reconstituted product to the patient is not made at a slow, steady rate, and (2) introducing practical guidance to healthcare professionals regarding how to mitigate this issue. The notification relates only to the listed batches, all future batches will have the correct PIL included." Healthcare professionals have received the accurate information and patients themselves need not take any action. They were informed: "Healthcare professionals should read the details in this notification and take this into account when reconstituting and administering these products. "Upon request, Brancaster Pharma Limited will provide hard copies of the updated PIL to wholesalers and pharmacies so that any packs can be supplemented with the correct PIL information. To request hard copies of the PIL, please contact [email protected] with your details, i.e. address, product with batch details, required number of leaflets." Advice for patients In its guidance for patients, the MHRA stated: "The quality of the powder for suspension for injection is not affected by this issue. The information missing from the Patient Information Leaflet (PIL) 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 when preparing the medication. No further action is required for the patient. "Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme."