MHRA has issued a Class 4 Medicines Defect Notification for Benzylpenicillin benzathine 1.2 Million I.U. and 2.4 Million I.U. powder for suspension for injection.
The marketing authorisation holder for the drug, Brancaster Pharma Limited, has informed the MHRA that a batch (72500105) of the above medicine contained an outdated Patient Information Leaflet (PIL).
Manufactured by Haupt Pharma Latina, Italy, these packs contain the previous PIL that was revised in April 2023, while the latest PIL is dated November 2025.
The quality of the powder for injection suspension is not affected by this issue.
The update was limited to the information in the section intended for healthcare professionals, and no further action is required for the patient.
The information relates to the preparation and administration of the injection.
The MHRA said that Brancaster Pharma will provide hard copies of the updated PIL to wholesalers and pharmacies so that any packs can be supplemented with the correct information.
