Class 4 Medicines Defect Information: ADVANZ PHARMA, MacroBID 100mg Prolonged-Release Capsules, EL (22)A/50
ADVANZ PHARMA has made the MHRA aware that certain batches of MacroBID 100mg Prolonged-Release Capsules have been packed with the incorrect Patient Information Leaflet (PIL).
MDR Number: MDR 206-11/22
Company name: ADVANZ PHARMA T/A Mercury Pharmaceuticals Limited
Product description: MacroBID 100mg Prolonged-Release Capsules, PL 12762/0052
Details of the affected batch:
|
Batch number |
Expiry date |
Pack size |
First distributed |
|
21001 |
05 2023 |
14 capsules |
12/08/2022 |
|
21002 |
05 2023 |
14 capsules |
12/08/2022 |
|
21003 |
05 2023 |
14 capsules |
18/08/2022 |
|
22001 |
12 2023 |
14 capsules |
10/08/2022 |
|
22002 |
12 2023 |
14 capsules |
16/09/2022 |
|
22003 |
12 2023 |
14 capsules |
23/09/2022 |
|
22006 |
03 2024 |
14 capsules |
28/09/2022 |
|
22007 |
04 2024 |
14 capsules |
03/10/2022 |
Brief description of problem:
ADVANZ PHARMA has made the MHRA aware that the above batches of MacroBID 100mg Prolonged-Release Capsules have been packed with the incorrect Patient Information Leaflet (PIL). The PIL does not contain important safety information relating to Possible Side effects and has minor editorial inconsistencies.
|
Missing safety information from the PIL: |
|
|
Section 4. Possible Side effects |
• Scarring due to damaged lung tissue may occur |
Please note, the minor editorial inconsistencies have not been listed as they have no impact on the information contained within the PIL. These will be corrected in all future batches of MacroBID 100mg Prolonged-Release Capsules.
Advice to Healthcare Professionals:
Healthcare professionals should note that there is no risk to product quality and efficacy, therefore the affected batches are not being recalled.
Healthcare professionals are advised to exercise caution when dispensing the above batches. Please provide a copy of the Summary of Product Characteristics (SmPC) when dispensing this medication to patients.
Download a copy of the current SmPC.
ADVANZ PHARMA has confirmed that all future batches will contain the correct PIL. Upon request, ADVANZ PHARMA will post hard copies of the updated PIL and/or SmPC to wholesalers and pharmacies so that any remaining stock in the dispensary can be supplemented with the correct PIL information.
Advice to Patients:
Patients should be aware that some packs of MacroBID 100mg Prolonged-Release Capsules may contain the incorrect Patient Information Leaflet (PIL). The incorrect PIL does not contain important safety information relating to Possible Side effects.
If you have any questions about your medicine or are concerned about side effects, talk to your healthcare professional. The medicine itself is not affected and any suspected adverse reactions should be reported via the MHRA Yellow Card scheme.
Company contacts for further information:
For further information, medical enquiries, stock information or request for printed copy of the associated SmPC, please contact telephone: + 44 (0) 208 5889 131 or via email: medicalinformation@advanzpharma.com.
To access the full recall: Class 4 Medicines Defect Information: ADVANZ PHARMA, MacroBID 100mg Prolonged-Release Capsules, EL (22)A/50