Dear Customer,
Sandoz Ltd. has issued a Class 4 Medicines Defect Information – Caution in Use. In relation to:
Omeprazole 10mg gastro-resistant capsules (PL 04416/0651)
Omeprazole 20mg gastro-resistant capsules (PL 04416/0652)
Mezzopram 10mg dispersible gastro-resistant tablets (PL 04416/1077)
Mezzopram 20mg dispersible gastro-resistant tablets (PL 04416/1078)
Mezzopram 40mg dispersible gastro-resistant tablets (PL 04416/1079)
Omeprazole 40mg powder for solution for infusion vials (PL 04416/0701)
Brief description of the problem
Sandoz Ltd. has informed the MHRA that there is missing safety information in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPCs) of the specific products listed in this notification (See attached)
The product information does not include a warning/precaution for severe cutaneous adverse reactions (SCAR) in section 4.4, and adverse events of drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP) in section 4.8 of the SmPC.
While the Sandoz CIU affects multiple products, the table below details the affected products and batches sold & being sold through by NVS.
| NVS Product Code(s) | Product Description | Affected Batch Number(s) | Expiry Date |
|---|---|---|---|
| 194530 | OMEPRAZOLE CAPS 20MG, PK28 | NJ0180 | 30/06/2025 |
| 508275 | OMEPRAZOLE PDR INF 40MG, PK5 | NA0074 NH1462 |
28/02/2025 31/07/2025 |
Advice for healthcare professionals
There is no risk to product quality or safety of the medicines because of this missing information. Therefore, the affected batches are not being recalled.
Due to supply considerations, batches listed as not yet distributed will not be repackaged with the updated PIL prior to distribution. The specified ‘Not yet distributed’ batches are scheduled to be distributed in the future to avoid any supply considerations.
What to do next – Please read the attached notification letter and follow advise (Please click here) bringing the issue to the attention of all relevant colleagues within your business.
