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 effects

Contact your doctor immediately if you notice signs of:

  • severe form of skin rash with flushing, fever, blisters or ulcers (Stevens-Johnson Syndrome)
  • severe rash involving reddening, peeling and swelling of the skin that resembles severe burns (Toxic epidermal necrolysis).

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

 

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