Class 4 Medicines Defect Information: Recordati Rare Diseases, Pedea 5 mg/ml solution for injection, EL(22)A/45
Recordati Rare Diseases T/A Recordati Rare Diseases UK Ltd has made the MHRA aware that specific batches of Pedea 5 mg/ml solution for injection have been packaged with the incorrect Product Information Leaflet (PIL).
MDR Number: MDR 014-10/22
Company name: Recordati Rare Diseases
Product description: Pedea 5 mg/ml solution for injection, PLGB 15266/0024, EU/1/04/284/001
Details of the affected batches:
Batch number |
Expiry date |
Pack size |
First distributed |
PD0G24E-07 |
10/2024 |
Box of 4 ampoules |
07/09/2022 |
PD0G24E-10 |
10/2024 |
Box of 4 ampoules |
Not yet distributed |
PF0G04E-03 |
10/2024 |
Box of 4 ampoules |
Not yet distributed |
Brief description of problem:
Recordati Rare Diseases T/A Recordati Rare Diseases UK Ltd has made the MHRA aware that specific batches of Pedea 5 mg/ml solution for injection have been packaged with the incorrect Product Information Leaflet (PIL). The incorrect PIL does not contain important safety information relating to severe skin reactions. In addition, the current Summary of Product Characteristics (SmPC) does not include the relevant safety information.
Missing information from the PIL:
Section 2. What you need to know before you use Pedea |
Warnings and precautions - Take special care with Pedea |
Section 4. Possible side effects |
Frequency “Not known” |
Missing information from the SmPC:
Section 4.4. Special warnings and precautions for use |
Severe skin reactions |
Section 4.8. Undesirable effects |
Skin and subcutaneous tissue disorders |
Advice to Healthcare Professionals:
There is no risk to product quality as a result of this issue, therefore the affected batches are not being recalled. Healthcare professionals will note that batch PD0G24E-10 and batch PF0G04E-03 are not yet distributed. The MHRA, in discussion with the Department of Health and Social Care, considers this product critical for patients, therefore these batches are included in the notification. Recordati Rare Diseases T/A Recordati Rare Diseases UK Ltd has confirmed that all future batches will contain the correct PIL and the SmPC details will be corrected.
Severe skin reactions are a well-known side effect of ibuprofen-containing medicines and non-steroidal anti-inflammatory medicines. Healthcare professionals should monitor patients who have been administered Pedea 5 mg/ml solution for injection and should discontinue the treatment course if any of the following side effects occur: skin rash, mucosal lesions, toxic epidermal necrolysis, exfoliative dermatitis, or any other sign of hypersensitivity.
Advice to Patients:
Patients are not required to take any action at this time. This product is administered by healthcare professionals directly. If you have concerns about a medicine you may be using, please contact your healthcare professional. Severe skin reactions are a well-known side effect of ibuprofen-containing medicines and non-steroidal anti-inflammatory medicines.
Patients should continue to be aware that in rare cases severe skin reactions occur. These include skin rash, mucosal lesions, toxic epidermal necrolysis, exfoliative dermatitis, or any other sign of hypersensitivity. If you notice any of these symptoms or have any concerns, please contact your healthcare professional immediately.
Company contacts for further information:
For further information, including medical enquiries and stock information, please contact:
Recordati Rare Diseases UK Ltd (local representative, WDA(H): 15720) on Tel: +44 (0)1491 414333 or +33 1 47 73 64 58 or email: RRDmedinfo@recordati.com
To access the full alert: Class 4 Medicines Defect Information: Recordati Rare Diseases, Pedea 5 mg/ml solution for injection, EL(22)A/45