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

2022-06-04 02:04:52 By : Ms. Matier Max

We use some essential cookies to make this website work.

We’d like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services.

We also use cookies set by other sites to help us deliver content from their services.

You can change your cookie settings at any time.

Search for a department and find out what the government is doing

Departments, agencies and public bodies

News stories, speeches, letters and notices

Detailed guidance, regulations and rules

Reports, analysis and official statistics

Data, Freedom of Information releases and corporate reports

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.

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

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.

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.

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.

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.

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

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.

Defective Medicines Report Centre 10 South Colonnade Canary Wharf London E14 4PU

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

Don’t include personal or financial information like your National Insurance number or credit card details.

To help us improve GOV.UK, we’d like to know more about your visit today. We’ll send you a link to a feedback form. It will take only 2 minutes to fill in. Don’t worry we won’t send you spam or share your email address with anyone.