Napralief 250mg Gastro-Resistant Tablets
What this means
The MHRA has issued a medicines recall or defect notification. Class 1: risk to life, immediate recall. Class 2: may cause mistreatment or harm, recall within 48 hours. Class 3: unlikely to cause harm, recall within 5 days. Class 4 (defect notification): no recall, caution in use. The medicine remains licensed; only the listed batches are affected. Do not stop treatment without speaking to your doctor or pharmacist.
Class 3 recall · DMRC- 39001103
| Product | Licence | Active ingredient | GTIN |
|---|---|---|---|
| Napralief 250mg Gastro-Resistant Tablets | PL: 02855/0340 | naproxen | 05012616268236 |
Batches (expiry): B51496 (31/10/2028), B51497 (31/10/2028), B51102 (31/07/2028)
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.