Class 4 MHRA drug alert – Phenobarbital Sodium 30mg/ml Injection (Martindale Pharma)

Class 4 MHRA drug alert – Phenobarbital Sodium 30mg/ml Injection (Martindale Pharma)

July 8, 2019

Class 4 MHRA drug alert – Phenobarbital Sodium 30mg/ml Injection (Martindale Pharma)

Drug alert number: EL (19)A/16

Date issued: 8th July 2019

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 pharmacy level caution in use for:

Phenobarbital Sodium 30mg/ml Injection (Martindale Pharma)

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 facility.

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

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.

For general enquiries please contact Nick Flynn by phone on 01708 336 412

PL number: PL 01883/6188R

To view the alert please visit the GOV.uk website.



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