Napp Pharmaceuticals Limited
OxyContin 20mg Sustained Release Tablets – PL 16950/0098
|Batch number||Expiration date||package size||First cast|
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.
|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.
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.
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.
Defective Drug Reporting Center
10 South Colonnade
Telephone +44 (0)20 3080 6574