MHRA Class 4 Medicines Defect Information: Venlafaxine XL 150mg, 225mg, 300mg prolonged-release tablets (Macarthys Laboratories t/a Martindale Pharma)
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.
