Omega Pharma recalls Napralief 250mg Gastro-Resistant Tablets over missing text on carton and leaflet

Official notice

The notice's own wording from MHRA.

Class 3 Medicines Recall: Omega Pharma Ltd, Napralief 250mg Gastro-Resistant Tablets, EL(26)A/21

Post Publication Note

This recall, first published on 23 April, has been updated. The Marketing Authorisation Holder has provided a corrected expiry date for one of the affected batches.

DMRC reference number

DMRC- 39001103

Marketing Authorisation Holder

Omega Pharma Ltd

Medicine Details

Napralief 250mg Gastro-Resistant Tablets PL: 02855/0340 Active ingredient: naproxen SNOMED code: N/A GTIN: 05012616268236

Affected Lot Batch Numbers

Batch No. | Expiry Date | Pack Size | First Distributed B51496 | 31/10/2028 | 9 Tablets | 31/12/2025 B51497 | 31/10/2028 | 9 Tablets | 03/02/2026 B51102 | 31/07/2028 | 9 Tablets | 23/12/2025

Background

Omega Pharma Ltd is recalling specific batches of Napralief 250mg Gastro-Resistant Tablets due to missing text in Section 2 and Section 3 of the Patient Information Leaflet (PIL) and on the Carton in packs of Napralief 250mg Gastro-resistant tablets. The Carton is missing the following wording: - Adults (18-50 years): On the first day take two tablets, followed by one tablet 6-8 hours later, if needed. If required on the second and third day, take one tablet every 6-8 hours. - Do not take more than three tablets a day. The PIL (Patient Information Leaflet) is missing the following wording highlighted in bold:

Advice for Healthcare Professionals:

Stop supplying the above batches immediately. Quarantine all stock and return it to your supplier using your supplier’s approved process.

Advice for Patients:

Do not take more than three tablets per day. Patients should be aware that the Patient Information Leaflet (PIL) and Carton in certain batches of Napralief 250mg Gastro-resistant tablets do not contain the most up to date safety information and should refer to the correct information listed above. No further action is required by patients. This recall is being undertaken as a precautionary measure and applies at Pharmacy and Wholesaler level. Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme .

Additional information:

For all medical information enquiries, stock control queries and information on this product, please email UKLOcustomerservice@perrigo.com or call +44 0203 598 9603. For stock control enquiries, please email customerservice@perrigouk.com or call +44 01226 704957 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: Omega Pharma Ltd, Napralief 250mg Gastro-Resistant Tablets, EL(26)A/21