Class 4

Class 4 Medicines Defect Information: Thornton & Ross, Covonia Night Time Formula and Covonia Original Bronchial Balsam, EL(22)A/30

MDR Number: 043-07/22

Company name: Thornton & Ross

Product description: Covonia Night Time Formula (P) PL 00240/0042

Details of the affected batch:

Batch Number

Expiry Date

Pack Size

First Distributed

00JE

July 2024

150ml

27/10/2021

80JG

August 2024

150ml

23/11/2021

Active Pharmaceutical Ingredient: Dextromethorphan Hydrobromide, Diphenhydramine Hydrochloride

Product description: Covonia Bronchial Balsam (P) PL 00240/5033R

Details of the affected batch:

Batch Number

Expiry Date

Pack Size

First Distributed

69KE

February 2025

150ml

24/05/2022

81KR

May 2025

150ml

28/06/2022

Active Pharmaceutical Ingredient: Dextromethorphan Hydrobromide, Menthol

Brief description of problem: Thornton & Ross have identified that the product labelling for the above batches of ‘Pharmacy’ medicines do not contain the ‘P’ symbol, due to a packaging error on the bottle.

Advice to Healthcare Professionals: The affected batches are not being recalled as there is no issue with product quality, and the Marketing Authorisation Holder (MAH) have only distributed these products to Pharmacy premises.

Healthcare professionals are advised to manage the supply of the above batches in line with the legal requirements for Pharmacy medicines. Pharmacy premises which have been distributed the impacted batches will also be contacted directly by the MAH regarding this labelling error.

Advice to Patients: Patients are not required to take any action at this time. Patients are reminded to take these medicines per the instructions of a pharmacist and those found on the product labelling. If you have any concerns about these medicines, please contact a pharmacist or healthcare professional for further advice.

Company contacts for further information:

For medical information and stock control queries please contact: Thornton & Ross on 01484 842217 or thorntonross@medinformation.co.uk

Full recall