Class 4 Medicines Defect Information: OxyContin 20 mg prolonged release tablets, EL (22)A/27

Napp Pharmaceuticals Limited have identified an error relating to the Braille printed on the cartons. The Braille message on the Oxycontin 20mg prolonged release tablets incorrectly states strength as 15mg

MDR Number: MDR 171-05/22

Company name: Napp Pharmaceuticals Limited

Product description: OxyContin 20 mg prolonged release tablets - PL 16950/0098

Details of the affected batches:

Brief description of problem:

Napp Pharmaceuticals Limited have identified an error relating to the Braille printed on the cartons. The Braille message on the Oxycontin 20mg prolonged release tablets incorrectly states strength as 15mg.

 

Advice to Healthcare Professionals:

The impacted products are within specification and there is no issue with product quality. Therefore, the affected batches are not being recalled.

Healthcare professionals should confirm when dispensing this product if this medicine is being collected on behalf of somebody else or if the patient will solely rely on Braille, and if needed explain the error in the Braille. The risk of an overdose remains low and any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

Advice to Patients:

Two batches of Oxycontin 20 mg prolonged release tablets have an incorrect strength printed in Braille on the product pack. The pack contains 20 mg tablets as prescribed and the medicine itself is not affected.

Patients are reminded to take the tablets as per the instructions from your prescriber and those found on the dispensing label. OxyContin prolonged release tablets must be swallowed whole and not broken, chewed or crushed or split.

Company contacts for further information:

For medical information or stock control queries please contact: Napp Pharmaceuticals - Tel. 01223 424 444, email medicalinformationuk@napp.co.uk or supplies.uk@napp.co.uk

Full recall