GovWire

Class 4 Medicines Defect Information: ADVANZ PHARMA, MacroBID 100mg Prolonged-Release Capsules, EL (22)A/50

Medicines Healthcare Products Regulatory Agency

December 5
11:00 2022

MDR number

MDR 206-11/22

Company name

ADVANZ PHARMA T/A Mercury Pharmaceuticals Limited

Product name

MacroBID 100mg Prolonged-Release Capsules, PL 12762/0052

SNOMED Code

517311000001102

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

Active Pharmaceutical Ingredient: Nitrofurantoin

Brief description of the 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

In rare cases, it may cause liver failure which may be fatal

Damage to bone marrow causing deficiency of the red blood cells (anaemia)

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 for 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 for 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.

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.

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

DMRC@mhra.gov.uk

Download document

Class 4 Medicines Defect Information: ADVANZ PHARMA, MacroBID 100mg Prolonged-Release Capsules, EL (22)A/50

Published 5 December 2022

Share This


Enjoyed this? Why not share it with others if you've found it useful by using one of the tools below: