Class 4 Medicines Defect Information: Esomeprazole 40mg Powder for Solution for Injection/Infusion, EL (22)A/26

DEMO SA PHARMACEUTICAL INDUSTRY has informed us that the Product Code/GTIN (PC) number found on the above batch is incorrect. The GTIN number that should have been allocated for this batch is 5200040321010.

MDR Number: MDR 024-04/22

Company name: DEMO SA PHARMACEUTICAL INDUSTRY

Product description: Esomeprazole 40mg Powder for Solution for Injection/Infusion - PL 55035/0001

Details of the affected batch:

Brief description of problem:

DEMO SA PHARMACEUTICAL INDUSTRY has informed us that the Product Code/GTIN (PC) number found on the above batch is incorrect. The GTIN number that should have been allocated for this batch is 5200040321010, however, 05026468771424 was applied in error which scans the batch as Acetylcysteine 200mg/ml injection (2g/10ml ampoules).

The product packed, patient information leaflet (PIL), and other primary data on the outer carton were confirmed as correct for Esomeprazole 40 mg powder for solution for injection and infusion, therefore this is batch is not subject to a recall.

There may be residual risk in cases where wholesalers and pharmacies use automated inventory system to dispense the affected batch within the pharmacy or wholesale facility.

Advice to Healthcare Professionals and Wholesalers:

• The GTIN barcode should not be used for any dispensing activities for the affected batch listed above. 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 to Patients:

There is a barcode error on the outer packaging of the product. The medicine itself is not affected and patients do not need to take any action

Company contacts for further information:

For medical information or stock control queries please contact Pantelis Krithimos at pkrithimos@demo.gr

To access the full recall: Class 4 Medicines Defect Information: Esomeprazole 40mg Powder for Solution for Injection/Infusion, EL (22)A/26