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, EL (22)A/15
Brancaster Pharma Limited have notified us of an issue relating to the label of the Water for Injections (solvent) packaged in each finished product pack.
MDR Number
MDR 033-03/22
Company name
Brancaster Pharma Limited
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
Brief description of the problem
Brancaster Pharma Limited have notified us 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.
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.
Further Information
For medical information and stock control queries please contact: safety@brancasterpharma.com
Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
Download document