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

Published On:

29 November 2022

Published In:

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 name

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

Batch number Expiry date Pack size First distributed
LC69391 07/2024 30 14/11/2022

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: [email protected]

To read the full original article please click HERE

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