Class 4 Medicines Defect Information, Diazepam 2mg/5ml Oral Solution Sugar Free (EL (21)A/07) (PL 0142/0103)
Accord-UK Ltd have informed us that important safety warnings for the excipient Propylene glycol are missing from the patient information leaflet (PIL).
MDR Number
MDR 006-03/21
Company name
Accord-UK Ltd
Product description
Diazepam 2mg/5ml Oral Solution Sugar Free
| Batch Number | Expiry Date | Pack Size | Livery | First Distributed |
|---|---|---|---|---|
| I54655 | 31/07/2021 | 100ml | Accord-UK Ltd | 11/12/2019 |
| I54797 | 30/09/2021 | 100ml | Accord-UK Ltd | 17/03/2020 |
| I54798 | 30/09/2021 | 100ml | Accord-UK Ltd | 17/03/2020 |
| I55223 | 28/02/2022 | 100ml | Accord-UK Ltd | 12/05/2020 |
| I55399 | 30/04/2022 | 100ml | Accord-UK Ltd | 27/07/2020 |
| I55506 | 31/05/2022 | 100ml | Accord-UK Ltd | 16/09/2020 |
| I55623 | 31/07/2022 | 100ml | Accord-UK Ltd | 23/11/2020 |
| I55894 | 31/10/2022 | 100ml | Accord-UK Ltd | 25/01/2021 |
| I54468 | 30/04/2021 | 100ml | Almus | 24/09/2019 |
| I54799 | 30/09/2021 | 100ml | Almus | 17/03/2020 |
| I55408 | 30/04/2022 | 100ml | Almus | 02/09/2020 |
| I55624 | 31/07/2022 | 100ml | Almus | 22/01/2021 |
The following batches have been packed and are waiting QP certification:
Diazepam 2mg/5ml Oral Solution Sugar Free
| Batch Number | Expiry Date | Pack Size | Description | First Distributed |
|---|---|---|---|---|
| I56131 | 31/01/2023 | 100ml | Accord-UK Ltd | - |
| I56055 | 31/12/2022 | 100ml | Accord-UK Ltd | - |
| I56132 | 31/01/2023 | 100ml | Accord-UK Ltd | - |
Brief description of the problem
Accord-UK Ltd have informed us that important safety warnings for the excipient Propylene glycol are missing from the patient information leaflet (PIL) used in the above batches (including the batches waiting QP certification) which should be present in accordance with the current annex to the Excipient Guidelines. Additionally, the warnings for sorbitol need updating although similar warnings are already present. The product is not subject to recall due to supply and shortage considerations.
The following excipient warnings have now been added to the PIL for future batches:
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Diazepam oral solution contains 409mg Propylene glycol per 5ml. If your child is less than 5 years old, talk to your doctor or pharmacist before giving them this medicine, in particular if they use other medicines that contain propylene glycol or alcohol. If you suffer from a liver or kidney disease, do not take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine.
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Diazepam oral solution contains 1.91g to 2.58g of sorbitol per 5ml solution. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine. Sorbitol may cause gastrointestinal discomfort and mild laxative effect. Calorific value 2.6 kcal/g sorbitol.
Advice for healthcare professionals
Healthcare professionals are requested when prescribing this medicine to inform patient’s and notify them of the information above. There is no risk to product quality as a result of this issue, therefore the associated batches are not being recalled at this time. The product is not subject to recall due to supply and shortage considerations.
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Accord-UK have confirmed that they will be providing hard copies of the updated PIL to wholesalers and pharmacies so that any remaining stock in the dispensary can be supplemented with the updated PIL information.
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Additionally, for all batches which have not been certified and are due to be released as per the notification above, Accord-UK have confirmed that they will be providing hard copies of the updated PIL with each delivery.
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Healthcare Professionals can also contact Accord-UK Ltd via the Customer Services Team on 0800373573 and request a hard copy of the updated PIL to be sent to them by post.
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The updated PIL information is available via the eMC website should healthcare professionals need access before hard copies are available: https://www.medicines.org.uk/emc/product/5783/smpc#gref
Further Information
For more information or medical information queries, please contact: Accord-UK Ltd Medical Information Department on 01271 385257
For stock control queries, please contact: Accord-UK Ltd Customer Services Team on 0800 373573
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.
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