GovWire

MDR number

MDR 072-10/22

Company name

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

Product name

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

Active Pharmaceutical Ingredient: venlafaxine hydrochloride

Brief description of the 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 for 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 for 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.

Further Information

For further information, medical enquiries and stock information, contact: Licensed@ethypharm.com

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

Telephone +44 (0)20 3080 6574

DMRC@mhra.gov.uk

Download Document

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