Class 4 Medicines Defect Information: Quadrant Pharmaceuticals Limited, Bezalip Mono 400mg Tablets, EL (22)A/38

Quadrant Pharmaceuticals Limited have informed the MHRA of an error with the Patient Information Leaflets (PILs) that have been packaged in various parallel imported batches.

MDR Number

MDR 025-09/22

Company name

Quadrant Pharmaceuticals Limited

Product description

Bezalip Mono 400mg Tablets 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.

Advice for patients:

Patients should be aware that the Patient Information Leaflet (PIL) in the above batches does not contain the most up to date safety information on skin side effects.

If you experience any of the side effects listed below, you should contact your doctor immediately:

  • severe form of skin rash with flushing, fever, blisters or ulcers
  • severe rash involving reddening, peeling and swelling of the skin that resembles severe burns

If you have any questions about your medicine or are concerned about side effects, talk to your healthcare professional.

The medicine itself is not affected and any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

Further Information:

For more information, medical or supply enquiries, please contact radoslaw.bandomir@maxearn.co.uk or natalie.harrison@hallohealthcaregroup.com

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

DMRC@mhra.gov.uk

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Class 4 Medicines Defect Information: Quadrant Pharmaceuticals Limited, Bezalip Mono 400mg Tablets, EL (22)A/38

Published 12 September 2022