GovWire

MDR number

MDR 072-10/22

Company name

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

Product name

Venlafaxine XL 150mg prolonged-release tablets, PL01883/0340

SNOMED Code

41468211000001100

Active Pharmaceutical Ingredient: venlafaxine hydrochloride

Product name

Venlafaxine XL 225mg prolonged-release tablets, PL01883/0341

SNOMED Code

41482811000001100

Active Pharmaceutical Ingredient: venlafaxine hydrochloride

Product name

Venlafaxine XL 300mg prolonged-release tablets, PL01883/0363

SNOMED Code

37997111000001100

Active Pharmaceutical Ingredient: venlafaxine hydrochloride

Brief description of the problem

Additional to the batches included in the previous Class 4 Medicines Notification (reference 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 prolonged-release tablets). It should instead reflect the generic name: Venlafaxine XL prolonged-release tablets. The code under the pre-printed barcode is correct.

Advice for healthcare professionals

There is no risk to product quality as a result of this issue, therefore the affected batches are not being recalled. In November 2022, Martindale Pharma had confirmed that no other batches were impacted. However, due to manufacturing issues, additional batches are now impacted by the same issue, including some batches that have not been distributed yet. Due to the market share of this product and consideration of the overall supply position, the batches above are not being recalled and continued distribution of the batches listed in the notification will take place.

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 150mg, 225mg, 300mg prolonged-release tablets, EL(23)A/10