MHRA Class 4 Medicines Defect Information: Bezalip Mono 400mg Tablets (Quadrant Pharmaceuticals Limited)
Class 4 Medicines Defect Information:
Bezalip Mono 400mg Tablets (Quadrant Pharmaceuticals Limited)
Drug alert number: EL (22)A/38
Date issued: 12 September 2022
The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for:
Bezalip Mono 400mg Tablets (Quadrant Pharmaceuticals Limited) PLPI 20774/0036
| Batch Number | Expiry Date | Pack Size | First Distributed |
| J3594 | 09/2025 | 30 | 17/11/2021 |
| J3741 | 09/2025 | 30 | 30/11/2021 |
| J3943 | 09/2025 | 30 | 15/12/2021 |
| K0077 | 01/2026 | 30 | 25/01/2022 |
| K0310 | 01/2026 | 30 | 08/02/2022 |
| K0327 | 12/2025 | 30 | 10/02/2022 |
| K0455 | 09/2025 | 30 | 11/02/2022 |
| K0547 | 12/2025 | 30 | 22/02/2022 |
| K0549 | 09/2025 | 30 | 22/02/2022 |
| K0562 | 01/2026 | 30 | 23/02/2022 |
| K2019 | 01/2027 | 30 | 10/06/2022 |
| K1994 | 01/2027 | 30 | 17/06/2022 |
| K2196 | 01/2027 | 30 | 01/07/2022 |
| K2274 | 10/2026 | 30 | 06/07/2022 |
| K2742 | 01/2027 | 30 | 26/07/2022 |
| K2943 | 01/2027 | 30 | 18/08/2022 |
| K3158 | 01/2027 | 30 | 24/08/2022 |
| K3134 | 01/2027 | 30 | 30/08/2022 |
Active Pharmaceutical Ingredient: bezafibrate
Brief description of the problem
Quadrant Pharmaceuticals Limited have informed the MHRA of an error with the Patient Information Leaflets (PILs) that have been packaged in the above parallel imported batches. The PIL included in the batches above is an older version of the PIL, which does not include the most up to date safety information.
The information missing from the PILs are as below:
Section 4. Possible side effectsContact your doctor immediately if you notice signs of:
|
Advice for healthcare professionals
There is no risk to product quality as a result of this issue, therefore the affected batches are not being recalled. Healthcare professionals are advised to discuss the missing information with patients and provide a copy of the updated PIL, where appropriate. MHRA PIL Link: Bezalip Mono 400mg Tablets PLPI 20774/0036.
Quadrant Pharmaceuticals Limited have confirmed that no further units of any of the above batches will be released, therefore this notification only applies to packs that are already at pharmacy or wholesaler level, or in the possession of patients.
Quadrant Pharmaceuticals Limited have also confirmed that all future batches will contain the updated PIL and that upon request they will send hard copies by post of the updated PIL to wholesalers and pharmacies, so that any remaining stock in the dispensary can be supplemented with the updated PIL information.
View full alert here
Further Information:
For more information, medical or supply enquiries, please contact radoslaw.bandomir@maxearn.co.uk or natalie.harrison@hallohealthcaregroup.com
