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Benzylpenicillin benzathine 1.2/2.4 Million I.U. powder and solvent alert

French labelling on water

March 18th 2022

Tagged: MHRA alert

By MHRA

Brancaster Pharma Limited has issued an alert regarding the label on four batches of benzylpenicillin benzathine 1.2/2.4 Million I.U. powder and solvent.

The affected batches are:

1.2 Million I.U.

Batch NumberExpiry DatePack SizeFirst Distributed
72C00215April 20211February 2020
72C00116August 20221December 2020

(awaiting distribution):

Batch NumberExpiry DatePack SizeFirst Distributed
72N00206May 20241

2.4 Million I.U.

Batch NumberExpiry DatePack SizeFirst Distributed
72C00216April 20211February 2020
72C00220August 20221August 2020
72C00223February 20231September 2021

(awaiting distribution)

Batch NumberExpiry DatePack SizeFirst Distributed
72N00207May 20241

The labelling issue relates to the 5mL ampoule of water for injections (solvent) which is written in French language, and relates to the approved French benzathine benzylpenicillin combination product (Extencilline).

The water for injection  is, however, identical to the approved UK product. All other product information, including the patient information leaflet, are in accordance with the marketing authorisations.

Batches are not being recalled. 

For medical information and stock control queries please contact:¬†[email protected]