Defect notice issued over packets with outdated information leaflets
The UK’s medicine watchdog has issued a defect notice on cartons of a powder antibiotic that have been released with outdated information leaflets.
The Medicines and Healthcare products Regulatory Agency (MHRA) said it has issued a class 4 medicines defect notification on benzylpenicillin benzathine 1.2 million I.U. and 2.4 million I.U. powder for suspension for injection.
The agency said it had been told by Brancaster Pharma Limited that two batches of benzylpenicillin benzathine contained out of date patient information leaflets.
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Affected lot batch numbers:
- 72500107 – expiring 31/10/2029 – pack size one – first distributed 26/06/2026
- 72500105 – expiring 31/10/2029 – pack size one – first distributed 26/06/2026
The packs, which were first distributed from Friday, contain the previous leaflet that was revised in April 2023 rather than the latest approved version from last November, the agency said.
Brancaster Pharma Limited will provide hard copies of the updated leaflets to wholesalers and pharmacies so that any packs can be supplemented with the correct information.
The MHRA stressed that the quality of the powder for suspension for injection is not affected by this issue.
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It said: ‘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 when preparing the medication. No further action is required for the patient.’
The 2025 update contained additional information intended for the healthcare professionals only section, the MHRA said.
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This included highlighting the potential for benzylpenicillin benzathine formulations to block the needle if intramuscular injections injection is not performed slowly and steadily as well as introducing guidance on how to mitigate this.
Hard copies of the leaflet can be requested directly from Brancaster Pharma Limited.
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