Class 4 Medicines Defect Information: Thornton & Ross, Covonia Night Time Formula and Covonia Original Bronchial Balsam, EL(22)A/30
Thornton & Ross have identified that the product labelling for some batches of ‘Pharmacy’ medicines do not contain the ‘P’ symbol, due to a packaging error on the bottle.
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 other healthcare professionals for further advice*.
*Text updated to correct typo
Further Information
For medical information and stock control queries please contact: Thornton & Ross on 01484 842217 or [email protected]
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
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