Class 4 Medicines defect information: Trimogal 100mg and 200mg tablets (Ennogen Pharma Limited)
Class 4 Medicines defect information: Trimogal 100mg and 200mg tablets (Ennogen Pharma Limited)
July 20, 2020
Class 4 Medicines Defect Information: Trimogal 100mg and 200mg tablets (Ennogen Pharma Limited)
Drug alert number: EL (20)A/31
Date issued: 20 July 2020
The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for:
Class 4 Medicines Defect Information: Trimogal 100mg and 200mg tablets (Ennogen Pharma Limited)
Ennogen Pharma Limited has informed us that the Patient Information Leaflets (PILs) within the packs for the above batches contain an error in Section 3 (How To Take Trimogal Tablets) with
regard to the dosage instructions for children under 6 years.
Section 3 (How To Take Trimogal Tablets)
| Incorrect information in the PILs of the affected batches | Correct information that should be in the PILs |
| Children aged 6 months to 6 years* 500mg twice a day (see * below) *For children a lower strength tablet or a syrup may be more suitable, especially for smaller children. |
Children under 6 years This tablet form of Trimogal is not recommended for use in children under 6 years |
Trimogal 100mg Tablets (POM) PL 40147/0082
| Batch Number | Expiry Date | Pack Size | First Distributed |
| 1402264 | 09/2021 | 28 | 03/02/2020 |
| 1402265 | 09/2021 | 28 | 03/02/2020 |
| 1402266 | 09/2021 | 28 | 09/03/2020 |
Trimogal 200mg Tablets (POM) PL 40147/0083
| Batch Number | Expiry Date | Pack Size | First Distributed |
| 1402171 | 07/2021 | 148 | 02/03/2020 |
| 1402262 | 08/2021 | 148 | 02/03/2020 |
| 1402263 | 08/2021 | 148 | 12/03/2020 |
Advice for healthcare professionals
When dispensing this medicine from the affected batches listed above, please ensure that the correct PIL is issued.
The correct PILs are available from the electronic medicines compendium (EMC) website by clicking on the links below:
PIL for Trimogal 100mg Tablets
PIL for Trimogal 200mg Tablets
Alternatively the correct PILs are also available from the MHRA website by clicking here.
View full alert here
Further Information
For more information or medical information queries, please contact:
Ennogen Pharma Ltd Units G2-G4 Riverside Industrial Estate
Riverside Way
Dartford
Kent
DA1 5BS
Email: Info@Ennogen.com
Tel: 01322 629 220
Posted in: Dispensing & Supply, PSNC News, Services & Commissioning
