Class 4 Medicines Defect Information:

Venlafaxine XL 150mg, 225mg, 300mg prolonged-release tablets (Macarthys Laboratories t/a Martindale Pharma)

Drug alert number: EL (23)A/10

Date issued: 16 March 2023

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for:

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

SNOMED Code: 41468211000001100

Batch number
Expiry date
Pack size
First distributed
LC70019
08/2025
30
10/02/2023
LC70020
08/2025
30
13/02/2023

Active Pharmaceutical Ingredient: venlafaxine hydrochloride

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

SNOMED Code: 41482811000001100

Batch number
Expiry date
Pack size
First distributed
LC70053
08/2025
30
09/02/2023
LC70054
08/2025
30
Not yet distributed

Active Pharmaceutical Ingredient: venlafaxine hydrochloride

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

SNOMED Code: 37997111000001100

Batch number
Expiry date
Pack size
First distributed
LC69693
07/2024
30
Not yet distributed
LC69699
07/2024
30
Not yet distributed
LC69701
07/2024
30
Not yet distributed

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.

View full alert here.

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.

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