Class 4 Medicines Defect Information: Sandoz Limited, Omeprazole products, EL(24)A/34
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.
DMRC reference number
DMRC 31246876
Company name
Sandoz Limited
Omeprazole 10mg gastro-resistant capsules, PL 04416/0651
SNOMED Code
3753411000001102
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| NR7436 | 31/08/2025 | 28 | 24/06/2024 |
| NP0188 | 31/08/2025 | 28 | 23/04/2024 |
Omeprazole 20mg gastro-resistant capsules, PL 04416/0652
SNOMED Code
3753611000001104
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| NK2790 | 31/05/2025 | 100 | 24/04/2024 |
| NP6341 | 31/10/2025 | 28 | 11/07/2024 |
| NP0340 | 30/09/2025 | 28 | 30/06/2024 |
| NP0338 | 30/09/2025 | 28 | 26/06/2024 |
| NP0196 | 31/08/2025 | 28 | 30/05/2024 |
| NP6261 | 30/09/2025 | 28 | 03/07/2024 |
| NP6340 | 30/09/2025 | 28 | 05/07/2024 |
| NP0192 | 31/08/2025 | 28 | 29/04/2024 |
| NN5783 | 31/08/2025 | 28 | 28/03/2024 |
| NN7643 | 30/09/2025 | 28 | 13/06/2024 |
| NM4605 | 31/08/2025 | 28 | 18/03/2024 |
| NM1246 | 31/07/2025 | 28 | 17/03/2024 |
| NK4294 | 31/07/2025 | 28 | 24/02/2024 |
| NK2489 | 31/07/2025 | 28 | 12/03/2024 |
| NM1246 | 31/07/2025 | 28 | 17/03/2024 |
| NK2486 | 31/07/2025 | 28 | 20/02/2024 |
| NK2484 | 30/06/2025 | 28 | 19/01/2024 |
| NJ0183 | 31/07/2025 | 28 | 01/02/2024 |
| NJ0182 | 31/07/2025 | 28 | 22/01/2024 |
| NJ6114 | 31/07/2025 | 28 | 16/02/2024 |
| NJ5014 | 31/07/2025 | 28 | 28/02/2024 |
| NJ6113 | 31/07/2025 | 28 | 14/02/2024 |
| NJ0179 | 30/06/2025 | 28 | 18/01/2024 |
| NJ0180 | 30/06/2025 | 28 | 19/01/2024 |
| NJ0181 | 30/06/2025 | 28 | 29/01/2024 |
| NH7770 | 31/07/2025 | 28 | 22/01/2024 |
| NH7771 | 30/06/2025 | 28 | 17/01/2024 |
| NH2809 | 30/06/2025 | 28 | 11/01/2024 |
| NG8624 | 31/05/2025 | 28 | 08/01/2024 |
| NG8998 | 31/05/2025 | 28 | 01/12/2023 |
| NG8621 | 31/05/2025 | 28 | 01/12/2023 |
| NG4125 | 31/05/2025 | 28 | 12/12/2023 |
| NG4126 | 31/05/2025 | 28 | 21/12/2023 |
| NG2539 | 31/05/2025 | 28 | 27/11/2023 |
| NW2409 | 30/11/2025 | 28 | Not yet distributed |
| NP6341 | 31/10/2025 | 28 | Not yet distributed |
| NP6342 | 31/10/2025 | 28 | Not yet distributed |
| NR2911 | 31/10/2025 | 28 | Not yet distributed |
| NT3562 | 31/10/2025 | 28 | Not yet distributed |
| NT4728 | 31/10/2025 | 28 | Not yet distributed |
| NT7236 | 30/11/2025 | 28 | Not yet distributed |
Mezzopram 10mg dispersible gastro-resistant tablets, PL 04416/1077
SNOMED Code
18503211000001105
| Batch Number | Expiry Date | Pack Size | First Distributed |
| NT9384 | 30/06/2025 | 28 | Not yet distributed |
| NS2301 | 30/06/2025 | 28 | 13/06/2024 |
| NM8348 | 30/04/2025 | 28 | 06/03/2024 |
| NG6059 | 31/12/2024 | 28 | 04/01/2024 |
| NE9955 | 31/10/2024 | 28 | 04/09/2023 |
| NX3026 | 31/10/2025 | 28 | Not yet distributed |
Mezzopram 20mg dispersible gastro-resistant tablets, PL 04416/1078
SNOMED Code
18503311000001102
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| NR1768 | 30/04/2025 | 28 | 09/05/2024 |
| NR1766 | 30/04/2025 | 28 | 05/04/2024 |
| NH0584 | 31/12/2024 | 28 | 11/12/2023 |
| NH0585 | 31/12/2024 | 28 | 22/01/2024 |
| NJ8635 | 31/12/2024 | 28 | 16/01/2024 |
| NH0587 | 31/12/2024 | 28 | 29/11/2023 |
| NH0583 | 31/10/2024 | 28 | 19/10/2023 |
Mezzopram 40mg dispersible gastro-resistant tablets, PL 04416/1079
SNOMED Code
18503411000001109
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| NR1765 | 31/10/2025 | 7 | 28/03/2024 |
| NC2107 | 31/12/2024 | 7 | 16/07/2023 |
Omeprazole 40mg powder for solution for infusion vials, PL 04416/0701
SNOMED Code
31685111000001103
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| NH1463 | 31/07/2025 | 1 | 30/05/2024 |
| NH1462 | 31/07/2025 | 1 | 04/06/2024 |
| NH1464 | 31/07/2025 | 1 | 09/01/2024 |
| NF5853 | 28/02/2025 | 1 | 26/10/2023 |
| NA0066 | 28/02/2025 | 1 | 11/08/2023 |
| NA0068 | 28/02/2025 | 1 | 02/11/2023 |
| NA0074 | 28/02/2025 | 1 | 08/02/2024 |
| NK2237AA | 31/08/2025 | 1 | Not yet distributed |
Active Pharmaceutical Ingredient: Omeprazole
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. 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.
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
Healthcare professionals are advised to review the information contained within this notification and take this into account when prescribing. If any of the above products are supplied and/or dispensed, please ensure that patients are aware of the missing information as highlighted above. It is important that any patients who notice relevant symptoms (see information in the ‘Advice for Patients’ section) should seek immediate medical advice. The following is a link to the updated SmPC:
Omeprazole 10mg gastro-resistant capsules (PL 04416/0651):
Omeprazole 10mg Capsules - Summary of Product Characteristics (SmPC) - (emc) (medicines.org.uk)
Omeprazole 20mg gastro-resistant capsules (PL 04416/0652):
Omeprazole 20mg Capsules - Summary of Product Characteristics (SmPC) - (emc) (medicines.org.uk)
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):
Advice for patients
Omeprazole can very rarely cause certain conditions that result in skin reactions like widespread rashes, peeling skin, scaly skin, bumps, blisters, or redness. These conditions can also cause other symptoms like fever and swollen lymph nodes, which you can feel as lumps under the skin. These conditions are known as ‘drug reaction with eosinophilia and systemic symptoms’ (DRESS) and ‘acute generalized exanthematous pustulosis’ (AGEP), and they occur in about 1 out of every 10,000 to 1,000 patients taking omeprazole. Information about these conditions is missing from the Patient Information Leaflet that comes with your medicine. This does not change or affect the quality of the product, you can safely continue your treatment. Should you experience any skin reactions during or after treatment, or if you have any other unusual symptoms such as high temperature, lumps or feeling unwell please contact your healthcare professional as soon as possible.
If you have any concerns about the information provided with your medicine, please speak with your pharmacy team in the first instance. If you have concerns about a medicine you may be using, please contact your healthcare professional.
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.
Further Information
For more information or medical information queries, please email [email protected], or telephone: +44 1276 698 101
For stock control queries, please email [email protected], or telephone: +44 1276 698607
Recipients of this Medicines Notification 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
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