Class 4 Medicines Defect Information: Macarthys Laboratories t/a Martindale Pharma, Venlafaxine XL 300 mg prolonged-release tablets, EL(22)A/47

Class 4 Medicines Defect Information: Macarthys Laboratories t/a Martindale Pharma, Venlafaxine XL 300 mg prolonged-release tablets, EL(22)A/47

Martindale Pharma has made the MHRA aware that the GTIN in the 2D barcode and the printed variable data represents the branded version of the product (Venlalic® XL 300 mg prolonged-release tablets).

MDR Number: MDR 072-10/22

Company name: Macarthys Laboratories t/a Martindale Pharma (an Ethypharm Group Company)

Product description: Venlafaxine XL 300 mg prolonged-release tablets, PL 01883/0363

Details of the affected batch:

Brief description of problem:

Martindale Pharma has made the MHRA aware that the GTIN in the 2D barcode and the printed variable data represents the branded version of the product (Venlalic® XL 300 mg prolonged-release tablets). It should instead reflect the generic name: Venlafaxine XL 300 mg prolonged-release tablets. The code for the printed barcode is correct.

Advice to Healthcare Professionals:

There is no risk to product quality as a result of this issue, therefore the affected batch is not being recalled. Martindale Pharma have confirmed that no other batches are impacted. Healthcare professionals are advised to exercise caution when dispensing the products. Additional precautions should be considered by wholesalers and pharmacies using automated inventory systems to dispense the affected batch within the pharmacy or wholesale facility.

Advice to Patients:

This notification relates to 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 further information, medical enquiries and stock information, contact: Licensed@ethypharm.com

Full recall