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
