Zentiva Paracetamol Soluble 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 4 recall · DMRC-35524103
| Product | Licence | Active ingredient | GTIN |
|---|---|---|---|
| Zentiva Paracetamol Soluble Tablets | PL 17780/0198 | Paracetamol |
Background: Zentiva Pharma UK Limited has informed the MHRA that the batches of soluble or effervescent tablets listed in the annexes are taking longer than expected to fully dissolve, resulting in an increase in residual material being observed. Additionally, some tablets may appear as having a rough surface on one side identified during further analysis. Following an investigation at the manufacturing site it is confirmed that the safety and efficacy of the tablets is not affected by these issues. The batches listed as ‘not yet distributed’ may also exhibit the same behaviour and take longer than expected to full dissolve . The MHRA, in discussion with Zentiva Pharma UK Limited, considers that there is no patient safety, quality or efficacy risk due to this issue, therefore these are included in the notification and the expected distribution dates for these batches will take place from 02 June 2