MHRA – Class 4 Medicines Defect Information: Venlafaxine XL 300 mg prolonged-release tablets (Macarthys Laboratories t/a Martindale Pharma)
Class 4 Medicines Defect Information:
Venlafaxine XL 300 mg prolonged-release tablets (Macarthys Laboratories t/a Martindale Pharma)
Drug alert number: EL (22)A/47
Date issued: 16 November 2022
The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for:
Venlafaxine XL 300 mg prolonged-release tablets, PL 01883/0363
|14 November 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.
View full alert here.
For further information, medical enquiries and stock information, contact: Licensed@ethypharm.com