Class 4 Drugs Defect Information: OxyContin 20mg Sustained Release Tablets, EL (22)A/27

0

MDR number

MDR 171-05/22

Company Name

Napp Pharmaceuticals Limited

Product Description

OxyContin 20mg Sustained Release Tablets – PL 16950/0098

Batch number Expiration date package size First cast
250630 08/2024 56 29/10/2021
250869 10/2024 56 02/14/2022

Active pharmaceutical ingredient: oxycodone hydrochloride

Brief description of the problem

Napp Pharmaceuticals Limited has identified an error related to the Braille printed on the cartons. The braille message on the Oxycontin 20mg extended release tablets incorrectly states that the strength is 15mg.

Product Publish Correct Braille
Oxycontin 20mg sustained release tablets, PL 16950/0098 The braille message incorrectly states that the strength is 15mg instead of 20mg The correct braille message should be:

Advice for healthcare professionals

The affected products conform to the specifications and there is no problem with the quality of the product. Therefore, the affected lots are not being recalled.

Healthcare professionals should confirm when dispensing this product whether this medicine is being collected on someone else’s behalf or whether the patient will rely solely on Braille, and if necessary, explain the error in the Braille. The risk of overdose remains low and any suspected side effects should also be reported via the MHRA yellow card scheme.

Patient advice

Two lots of Oxycontin 20mg extended release tablets have the incorrect strength printed in Braille on the product packaging. The box contains 20mg tablets as prescribed and the medicine itself is unaffected.

Patients are reminded to take the tablets according to the instructions of their prescribing doctor and those on the dispensing label. OxyContin extended-release tablets should be swallowed whole and not broken, chewed, crushed or divided.

Further information

For medical information or inventory control questions, please contact: Napp Pharmaceuticals – Tel. 01223 424 444, email [email protected] or [email protected]

Recipients of this drug notification should bring it to the attention of affected contacts with a copy of this notice. Regional NHS teams are asked to pass it on to dispensing pharmacists and GPs for information.

yours faithfully

Defective Drug Reporting Center

10 South Colonnade

Canary Wharf

London

E14 4PU

Telephone +44 (0)20 3080 6574

[email protected]

Download documents

Class 4 Drugs Defect Information: OxyContin 20mg Sustained Release Tablets, EL (22)A/27

Correct braille image

Share.

Comments are closed.