Source: MHRA/ Gov.uk 1st June 2022
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
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 250630 | 08/2024 | 56’s | 29/10/2021 |
| 250869 | 10/2024 | 56’s | 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.
| Product | Issue | Correct Braille |
|---|---|---|
| Oxycontin 20mg prolonged release tablets, PL 16950/0098 | Braille message incorrectly states strength as 15mg rather than 20mg | The correct Braille message should read:  |
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.
Advice for 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.
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
Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
Yours faithfully
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
Download documents
Click here for the source.
