MHRA Class 4 Medicines Defect Information: OxyContin 20mg prolonged release tablets
Class 4 Medicines Defect Information: OxyContin 20 mg prolonged release tablets
Drug alert number: EL (22)A/27
Date issued: 01 June 2022
The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for:
OxyContin 20 mg prolonged release tablets (PL 16950/0098)
|Batch Number||Pack Size||Expiry Date||First Distributed|
|250630||56 tablets||08 2024||29/10/2021|
|250869||56 tablets||10 2024||14/02/2022|
Active Pharmaceutical Ingredient: Oxycodone Hydrochloride.
Brief description of the 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 for 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.
View full alert here