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

Further Information

For medical information and stock control queries please contact: Napp Pharmaceuticals – Tel. 01223
424444, email medicalinformationuk@napp.co.uk or supplies.uk@napp.co.uk

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