Class 4 Medicines Defect Information: Esomeprazole 40mg Powder for Solution for Injection/Infusion (DEMO SA PHARMACEUTICAL INDUSTRY)

Class 4 Medicines Defect Information: Esomeprazole 40mg Powder for Solution for Injection/Infusion (DEMO SA PHARMACEUTICAL INDUSTRY)

Drug alert number: EL (22)A/26

Date issued: 31 May 2022

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for:

Class 4 Medicines Defect Information: Esomeprazole 40mg Powder for Solution for Injection/Infusion (DEMO SA PHARMACEUTICAL INDUSTRY)

Esomeprazole 40mg Powder for Solution for Injection/Infusion – PL 55035/0001

Active Pharmaceutical Ingredients: Piperacillin (as sodium salt) and Tazobactam (as sodium salt).

Brief description of the 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 for healthcare professionals

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.

View full alert here

Further Information

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