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Class 4 Medicines Defect Information: OxyContin 20 mg prolonged release tablets, EL (22)A/27

Published On:

1 June 2022

Published In:

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: Correct Braille message

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 [email protected] or [email protected]

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.

To read the full original article please click HERE

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