MHRA Class 4 Medicines Defect Information: Covonia Night Time Formula and Covonia Original Bronchial Balsam

Class 4 Medicines Defect Information:

Covonia Night Time Formula and Covonia Original Bronchial Balsam (Thornton & Ross)

Drug alert number: EL (22)A/30

Date issued: 14 July 2022

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

Covonia Night Time Formula (P) (PL 00240/0042)

Batch Number Pack Size Expiry Date First Distributed
00JE 150ml July 2024 27/10/2021
80JG 150ml August 2024 23/11/2021

Active Pharmaceutical Ingredient: Dextromethorphan Hydrobromide, Diphenhydramine Hydrochloride.

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

Batch Number Pack Size Expiry Date First Distributed
69KE 150ml February 2025 24/05/2022
81KR 150ml May 2025 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.

View full alert here

Further Information

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

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