Class 4 Medicines Defect Information: Macarthys Laboratories t/a Martindale Pharma, Venlafaxine XL 300 mg prolonged-release tablets, 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 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: 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
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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