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

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

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

Brief description of the problem

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.

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 for pharmacists

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.

Advice for wholesalers

The barcode should not be used for wholesaling 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 wholesalers, please forward a copy of this Alert to them.

Contact details for further information

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

Additional information

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter.

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

Published 8 July 2019