Class 4 Medicines Defect Information: Macarthys Laboratories t/a Martindale Pharma, Venlafaxine XL 150mg, 225mg, 300mg prolonged-release tablets, EL(23)A/10
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).
MDR Number: MDR 072-10/22
Company name: Macarthys Laboratories t/a Martindale Pharma (an Ethypharm Group Company)
Product description: Venlafaxine XL 150mg prolonged-release tablets, PL01883/0340
SNOMED Code: 41468211000001100
Details of the affected batch:
|
Batch No |
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
Product description: Venlafaxine XL 225mg prolonged-release tablets, PL01883/0341
SNOMED Code: 41482811000001100
|
Batch No |
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
Product description: Venlafaxine XL 300mg prolonged-release tablets, PL01883/0363
SNOMED Code: 37997111000001100
|
Batch No |
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 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 to 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 to 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.
Company contacts for further information:
For further information, medical enquiries and stock information, contact: Licensed@ethypharm.com.
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