MHRA Class 4 Medicines Defect Notification: Benzylpenicillin benzathine 1.2 Million I.U. and 2.4 Million I.U. powder for suspension for injection (Brancaster Pharma Limited)

MHRA Class 4 Medicines Defect Notification: Benzylpenicillin benzathine 1.2 Million I.U. and 2.4 Million I.U. powder for suspension for injection (Brancaster Pharma Limited)

Drug alert number: EL(26)A/30

Date issued: 29 June 2026

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the Patient Information Leaflet (PIL) in the cartons for the batches listed in this notification were released with an outdated PIL.

DMRC reference number: DMRC- 39917416

Marketing Authorisation Holder: Brancaster Pharma Limited

Medicine Details

Product name: Benzylpenicillin benzathine 1.2 Million I.U. powder for suspension for injection

PL: 41542/0006

Active ingredient: benzylpenicillin benzathine

SNOMED code: 42677711000001104

GTIN: 05060432470258

Manufactured by: Haupt Pharma Latina, Italy

Affected Lot Batch Numbers

Product name: Benzylpenicillin benzathine 2.4 Million I.U. powder for suspension for injection

PL: 41542/0007

Active ingredient: benzylpenicillin benzathine

SNOMED code:44166911000001101

GTIN:05060432470265

Affected Lot Batch Numbers

Background

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the Patient Information Leaflet (PIL) in the cartons for the batches listed in this notification were released with an outdated PIL.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.

Advice for healthcare professionals

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 enquiries@brancasterpharma.com with your details, i.e. address, product with batch details, required number of leaflets.

The correct PIL is available:
Click here

The information in the updated PIL reflects the current section 6.6 of the SmPC:
Click here

View the full MHRA alert here.

Advice for Healthcare Professionals to Provide to Patients:

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.

Additional information:

For all medical information enquiries and information on this product, please email safety@brancasterpharma.com, or telephone +44 (0) 1737 243 407.

For stock control enquiries please email enquiries@brancasterpharma.com, or telephone +44 (0) 1737 243 407.