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8 July 2019 by Jacquie Lee

Class 4 Medicines Defect Information: Phenobarbital Sodium 30mg/ml Injection (MDR 48-02/19)

  • Wales
  • England
  • Scotland
  • Northern Ireland

Martindale Pharma has informed the Medicines and Healthcare products Regulatory Agency (MHRA) that the EAN bar code for the following batches is incorrect.

MDR Number

MDR 48-02/19

Company name

Martindale Pharma

Product description

Phenobarbital Sodium 30mg/ml Injection

PL 01883/6188R

Details of the affected batch:

Batch number

Expiry Date

Pack size

First distributed

0101620

10/2020

1 x 10

21/12/2018

0102721

11/2020

1 x 10

31/01/2019

0104613

11/2020

1 x 10

05/03/2019

0104155

10/2020

1 x 10

07/01/2019


Martindale Pharma has informed MHRA that the EAN bar code on the above batches is incorrect. The barcode reference should have been 5014124170278 however code 501412470261 was applied to the carton in error. The incorrect barcode scans the batch as Phenobarbital Sodium Injection 200mg/ml.

Brief description of problem

All other information on the carton and ampoule label is correct for the above batches of Phenobarbital Sodium 30mg/ml Solution for Injection.

The barcode error increases the risk of product mix up when an automated inventory system is used to dispense the affected batch within the pharmacy or wholesale facility.

 Advice to Healthcare professionals

The barcode should not be used for any dispensing activities for this batch. Please bring this notice to the attention of all relevant staff within your facility.

If you have supplied units from this batch to any other pharmacy or clinic, please forward a copy of this Alert to them.

Company contacts for further information

For any enquiries please contact Nick Flynn, Tel: 01708 336 412

To access the full recall:

https://assets.publishing.service.gov.uk/media/5d231a1340f0b609c92101eb/EL__19__A_16_Final_.pdf

Drug alert class 4

Drug alert class 4

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