Class 4 Medicines Defect Information: Metronidazole 200 mg/5 ml Oral Suspension (Drugsrus Limited / Dawa Limited)

Class 4 Medicines Defect Information:

Metronidazole 200 mg/5 ml Oral Suspension (Drugsrus Limited / Dawa Limited)

Drug alert number: EL (23)A/19

Date issued: 23 May 2023

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

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

Batch No Expiry Date Pack Size First Distributed
C20070 03/2025 100ml 11/10/2022
C20071 03/2025 100ml 24/01/2023
C20072 03/2025 100ml 28/12/2022

Active Pharmaceutical Ingredient: metronidazole benzoate

Brief description of the 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 for 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.

View full alert here.

Further Information

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