Class 4 Medicines Defect Information, Caffeine Citrate 10mg/ml Solution for Injection, (PL 01883/0344), EL (21)A/09

Macarthys Laboratories Limited T/A Martindale Pharma has informed us that the EAN barcode on the outer carton of a specific batch of Caffeine Citrate 10mg/ml Solution for Injection is incorrect.

MDR Number

MDR 116-03/21

Company name

Macarthys Laboratories Limited T/A Martindale Pharma

Product description

Batch number: 0134161

Expiry Date: 12/2023

Pack Size: 1 x 10

First Distributed: 27/01/2021

Active Pharmaceutical Ingredients: caffeine citrate

Brief description of the problem

Macarthys Laboratories Limited T/A Martindale Pharma has informed us that the EAN barcode on the outer carton of the above batch is incorrect. When scanned, the incorrect barcode shows the batch as Martindale Pharma’s Methylthioninium Chloride Injection 1% 10 X 10ml, which has been discontinued. All other information on the outer carton (including the 2D code), as well as the immediate packaging, is correct.

The incorrect EAN barcode on the carton is 5014124170667.

The correct EAN barcode should have been 5014124171855.

Advice for healthcare professionals

Wholesalers and healthcare professionals are advised to exercise caution when distributing, supplying and/or dispensing this product. Whilst EAN barcodes are not the primary source of product identification, these are mainly used in automated inventory systems by wholesalers and pharmacies. Therefore, it is advised that the scanning of this barcode should not be used for any supply processes or activities relating to this batch.

There is no risk to product quality as a result of this issue, therefore this batch is not being recalled.

Further Information

For more information or medical information queries, please contact: medinfo@ethypharm.co.uk

For stock control queries, please contact: Alan.josiah@ethypharm.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.

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Class 4 Medicines Defect Information, Caffeine Citrate 10mg/ml Solution for Injection, (PL 01883/0344), EL (21)A/09

Published 18 March 2021