GovWire

MDR Number

MDR 043-07/22

Company name

Thornton & Ross

Product description

Covonia Night Time Formula (P) PL 00240/0042

Active Pharmaceutical Ingredient: Dextromethorphan Hydrobromide, Diphenhydramine Hydrochloride

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

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

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