MHRA Class 4 Medicines Defect Information: MacroBID 100mg Prolonged-Release Capsules (ADVANZ PHARMA)

Class 4 Medicines Defect Information:

MacroBID 100mg Prolonged-Release Capsules (ADVANZ PHARMA)

Drug alert number: EL (22)A/50

Date issued: 05 December 2022

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

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

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 03/20/2022

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.

View full alert here

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.

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