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Class 3 Medicines Recall: Orion Pharma (UK) Ltd, Eldepryl 5mg Tablets (selegiline), EL(24)A/42

Medicines Healthcare Products Regulatory Agency

September 18
10:27 2024

DMRC reference number

DMRC-31814730

Orion Pharma (UK) Ltd

Product name

Eldepryl 5mg Tablets, PL 27925/0004

SNOMED Code

669511000001106

Batch No Expiry Date Pack Size First Distributed
2167829 07.2026 100 tablets 22.09.2023

Active Pharmaceutical Ingredient: Selegiline hydrochloride

Brief description of the problem

Orion Pharma (UK) Ltd is recalling the above batch as a precautionary measure due to an out of specification result in the assay result during the follow up stability study of the batch. Only the batch in the table is affected.

Advice for healthcare professionals

Stop supplying the above batch immediately. Quarantine all remaining stock and return it to your supplier using your suppliers approved process.

Advice for patients

No further action is required by patients as this is a Pharmacy and Wholesaler level recall. Patients should continue to take medicines from these batches as prescribed by your healthcare professional.

Patients who experience adverse reactions or have any questions about the medication, should seek medical attention. Any suspected adverse reactions should also be reported via theMHRA Yellow Card scheme.

Further Information

For medical information enquiries please email UK.MedicalInformation@orionpharma.com, or telephone 01635 520300.

For stock control enquiries please email orionukar&customerservices@orionpharma.com.

Recipients of this Medicines Recall 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

DMRC@mhra.gov.uk

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Class 3 Medicines Recall: Orion Pharma (UK) Ltd, Eldepryl 5mg Tablets (selegiline), EL(24)A/42

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Published 18 September 2024

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