Class 4 Medicines Defect Information: Benzylpenicillin benzathine 1.2 Million I.U. and 2.4 Million I.U. powder and solvent for suspension for injection

Class 4 Medicines Defect Information: Latuda film-coated tablets (CNX Therapeutics Ltd)

Drug alert number: EL (22)A/15

Date issued: 17 March 2022

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for: Benzylpenicillin benzathine 1.2 Million I.U. and 2.4 Million I.U. powder and solvent for suspension for injection

Brief description of the problem

Brancaster Pharma Limited have notified MHRA of an issue relating to the label affixed to the 5mL ampoule of Water for Injections (solvent) that is packaged in each finished product pack.

This label is not in accordance with the approved marketing authorisation: it is written in French language rather than English, and relates to the approved French benzathine benzylpenicillin combination product (“Extencilline”).

The Water for Injections for the French product is identical to the approved UK product, except for the labelling on the ampoule. The label affixed to the vials of benzylpenicillin benzathine powder, outer carton of the finished product packs and patient information leaflets for the above batches are in accordance with the marketing authorisations.

Product description

Benzylpenicillin benzathine 1.2 Million I.U. powder and solvent for suspension for injection PL 41542/0006

Batch Number Expiry Date Pack Size First Distributed
72C00215 April 2021 1 February 2020
72C00116 August 2022 1 December 2020

The batch below has been packed and is awaiting distribution:

Batch Number Expiry Date Pack Size First Distributed
72N00206 May 2024 1

Benzylpenicillin benzathine 2.4 Million I.U. powder and solvent for suspension for injection PL 41542/0007

Batch Number Expiry Date Pack Size First Distributed
72C00216 April 2021 1 February 2020
72C00220 August 2022 1 August 2020
72C00223 February 2023 1 September 2021

The batch below has been packed and is awaiting distribution:

Batch Number Expiry Date Pack Size First Distributed
72N00207 May 2024 1

Active Pharmaceutical Ingredients: Benzylpenicillin benzathine; Water for Injections

Advice for healthcare professionals

Healthcare professionals are advised to note this issue. The Water for Injections ampoule contains 5mL water for injections; there is no risk to the quality of the reconstituted injection as a result of this issue, therefore the affected batches are not being recalled.

View full alert here

Further Information

For medical information and stock control queries please contact: safety@brancasterpharma.com

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