Class 4 Medicines Defect Information: Omeprazole products (Sandoz Limited)

Drug alert number: EL (24)A/34

Date issued: 07 August 2024

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for: Omeprazole products (Sandoz Limited)

Company name: Sandoz Limited

Product name: 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

Product name: 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

Product name: 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

Product name: 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

Product name: 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

Product name: 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 10 mg Dispersible Gastro-resistant Tablets – Summary of Product Characteristics (SmPC) – (emc) (medicines.org.uk)

Mezzopram 20mg dispersible gastro-resistant tablets (PL 04416/1078):

Mezzopram 20 mg Dispersible Gastro-resistant Tablets – Summary of Product Characteristics (SmPC) – (emc) (medicines.org.uk)

Mezzopram 40mg dispersible gastro-resistant tablets (PL 04416/1079):

Mezzopram 40 mg Dispersible Gastro-resistant Tablets – Summary of Product Characteristics (SmPC) – (emc) (medicines.org.uk)

Omeprazole 40mg powder for solution for infusion vials (PL 04416/0701):

Omeprazole 40 mg Powder for Solution for Infusion – Summary of Product Characteristics (SmPC) – (emc) (medicines.org.uk)

View full alert here.

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 sandozgb@EU.propharmagroup.com, or telephone: 01276 698 101

For stock control queries, please email sales.sandoz-gb@sandoz.com, or telephone: 01276 698607

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