News » MHRA alert » Alert: Benzylpenicillin benzathine powder for suspension for injection
June 30th 2026
Brancaster Pharma Limited has advised that the Patient Information Leaflet (PIL) in one batch each of 1.2 Million IU and 2.4 Million IU Benzylpenicillin benzathine powder for suspension for injection is obsolete.
The affected batches are:
Benzylpenicillin benzathine 1.2 Million I.U. powder for suspension for injection
|
Batch No. |
Expiry Date |
Pack Size |
First Distributed |
|
72500107 |
31/10/2029 |
1 |
26/06/2026 |
Benzylpenicillin benzathine 2.4 Million I.U. powder for suspension for injection
|
Batch No. |
Expiry Date |
Pack Size |
First Distributed |
|
72500105 |
31/10/2029 |
1 |
26/06/2026 |
The error relates to the 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.
Healthcare professionals should consider this information when reconstituting and administering these products.
The correct PIL is available online
The quality of the powder for suspension for injection is not affected by this issue.
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.
