Class 3 Recall - Omeprazole 20 mg/15 ml Oral Solution Active

CLASS 3 RECALL

PLEASE READ AND CONFIRM THAT YOU HAVE RECEIVED THIS.

We have received a Class 3 Recall from Glenmark Pharmaceuticals

on Omeprazole 20 mg/15 ml Oral Solution

• MHRA drug alert link https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-omeprazole-20-mg-slash-15-ml-oral-solution-glenmark-pharmaceuticals-europe-ltd-el-25-a-slash-30?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=e78400fa-abcd-4b11-8293-0ab9b0eb4e68&utm_content=immediately

• MHRA ref: DMRC-35139406

5. Reason: Glenmark Pharmaceuticals Europe Ltd is recalling a specific batch of Omeprazole Oral Solution as a precautionary measure due to an investigation following a customer complaint indicating precipitation and discoloration of the product in the bottles. A root cause has identified that this is a result of an inadequate assembly of the plunger stem and the cup which could lead to a premature mixing of the two components of the medicinal product.

Please can you ensure that your stores quarantine the product listed below.

Further Information

For medical information enquiries please use the following options by phone +44 08004 580 383 or email medical_information@glenmarkpharma.com

For stock control enquiries please email orders.uk@glenmarkpharma.com

Please return all affected stock to your original supplier for credit. Unfortunately, we can only accept stock purchased from us (Alliance Healthcare Distribution Limited). Any other stock will be returned to your stores/Pharmacies.

Please note that anything not returned to us, or notified to us, within 3 months of this notification, cannot be reimbursed by way of a credit.