GovWire

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

Medicines Healthcare Products Regulatory Agency

July 14
09:59 2022

MDR Number

MDR 043-07/22

Company name

Thornton & Ross

Product description

Covonia Night Time Formula (P) PL 00240/0042

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

Covonia Original Bronchial Balsam (P) PL 00240/5033R

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 the 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 for 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 for 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.

Further Information

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

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

Published 14 July 2022

Recent Comments

Follow Us on Twitter

Share This


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