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

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

Batch Number Expiry Date Pack Size First Distributed
2200855 Dec 2023 1 vial per box 1 March 2022

Active Pharmaceutical Ingredient: esomeprazole

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.

Advice for 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 for 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.

Further Information

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.

Yours faithfully

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

Telephone +44 (0)20 3080 6574

DMRC@mhra.gov.uk

Download document

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

Comments

Post a Comment

Popular posts from this blog

Lokelma: Uses, Dosage, Side Effects, Cost, and More - Healthline

Image
Like most drugs, Lokelma may cause mild or serious side effects. The lists below describe some of the more common side effects that Lokelma may cause. These lists don't include all the possible side effects. Keep in mind that side effects of a drug can depend on: your age other health conditions you have other medications you take Your doctor or pharmacist can tell you more about the potential side effects of Lokelma. They can also suggest ways to help reduce side effects. Mild side effects Swelling is the only mild side effect that has been reported in studies. For details about swelling, see "Side effect focus" below. And to learn about side effects in studies, you can see Lokelma's prescribing information. Mild side effects of many drugs may go away within a few days or a couple of weeks. But if they become bothersome, talk with your doctor or pharmacist. Serious side effects Serious side effects of Lokelma can occur, but they aren't common. If you have serious...
Read more