Class 4

Class 4 Medicines Defect Information: Drugsrus Limited / Dawa Limited, Metronidazole 200 mg/5 ml Oral Suspension, EL (23)A/19

Drugsrus Limited has informed the MHRA that a small number of bottles of Metronidazole 200 mg/5 ml Oral Suspension 100ml are leaking from the cap.

MDR Number: MDR 043-03/23

Company name: Drugsrus Limited / Dawa Limited

Product description: Metronidazole 200 mg/5 ml Oral Suspension, PL 30684/0236

Details of the affected batches:

Batch No

Expiry Date

Pack Size

First Distributed

C20070

03/2025

100 ml

11/10/2022

C20071

03/2025

100 ml

24/01/2023

C20072

03/2025

100 ml

28/12/2022

Brief description of problem:

Drugsrus Limited has informed the MHRA that a small number of bottles of Metronidazole 200 mg/5 ml Oral Suspension 100ml are leaking from the cap. The probable root cause for this defect is related to the possibility of a slight defect in the cap or bottle threads. Only the batches listed in this notification are affected. Due to the very low number of complaints received and the high visibility of the defect usually prior to dispensing, the product is not currently being recalled.

Advice to Healthcare Professionals:

Healthcare professionals are advised to check any incoming bottles from the batches listed above for leaks from the cap.

Do not dispense any bottles that are found to be leaking. Quarantine any affected bottles immediately. Contact Drugsrus Limited (see Further Information section) for replacement and further advice.

Advice to Patients:

If you have received a bottle of Metronidazole 200 mg/5 ml Oral Suspension 100ml that is leaking, contact your pharmacy team to arrange a replacement. Please return the leaking bottle to the pharmacy – they will provide you with another bottle so you can complete your course of treatment.

If you have concerns about a medicine you may be using, please contact your healthcare professional. Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

Company contacts for further information:

For more information, medical or supply enquiries, please contact Drugsrus Limited on 020 8423 3800, or email info@drugsrus.co.uk.

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