Class 4

Class 4 Medicines Defect Information, Rosuvastatin 5 mg, 10 mg, 20 mg and 40 mg film-coated tablets (EL (21)A/21)

Accord Healthcare have informed us of an error with the patient information leaflets (PILs) that have been packaged in some Rosuvastatin products.

MDR Number MDR 197-08/21

Company name Accord Healthcare Limited

Product description

Rosuvastatin 5 mg film-coated tablets PL 20075/0402

Batch Number

Expiry Date

Pack Size

First Distributed

P2003918

05/2022

28

18-10-2020

P2004589

05/2022

28

27-01-2021

P2006170

10/2022

28

17-03-2021

P2100919

12/2022

28

17-06-2021

P2100504

12/2022

28

28-06-2021

P2100505

12/2022

28

28-06-2021

P2102016

01/2023

28

01-08-2021

P2102004

12/2022

28

07-07-2021

Rosuvastatin 10 mg film-coated tablets PL 20075/0403

Batch Number

Expiry Date

Pack Size

First Distributed

P2004270

04/2022

28

08-11-2020

P2005749

08/2022

28

07-04-2021

P2005771

08/2022

28

01-04-2021

P2006215

11/2022

28

13-06-2021

P2100654

01/2023

28

17-05-2021

P2100655

01/2023

28

13-05-2021

P2101700

01/2023

28

07-07-2021

P2101824

02/2023

28

04-07-2021

P2101396

02/2023

28

07-07-2021

Rosuvastatin 20 mg film-coated tablets PL 20075/0404

Batch Number

Expiry Date

Pack Size

First Distributed

P2003123A

03/2022

28

27-05-2021

P2101390

12/2022

28

27-06-2021

Rosuvastatin 40 mg film-coated tablets PL 20075/0405

Batch Number

Expiry Date

Pack Size

First Distributed

P2101978

02/2023

28

04-07-2021

Brief description of problem

Accord Healthcare have informed us of an error with the patient information leaflets (PILs) that have been packaged in the above batches of products. These were an older version of the PIL which did not include the most up to date safety information.

The information missing from the PILs are as below:

Section 2 Other medicines and Rosuvastatin tablets:

Tell your doctor if you are taking any of the following:

Regorafenib (used to treat cancer), any of the following drugs used to treat viral infections, including HIV or hepatitis C infection, alone or in combination (please see Warnings and precautions): atazanavir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

Section 4 Possible side effects:

Stop taking Rosuvastatin tablets and talk to your doctor immediately

If you experience muscle rupture

If you have lupus-like disease syndrome (including rash, joint disorders and effects on blood cells).

Rosuvastatin tablets may cause the following possible side effects:

Rare (may affect up to 1 in 1,000 people)

Severe allergic reaction – signs include swelling of the face, lips, tongue and/or throat, difficulty in swallowing and breathing, a severe itching of the skin (with raised lumps). If you think you are having an allergic reaction, then stop taking Rosuvastatin tablets and seek medical help immediately

Muscle damage in adults – as a precaution, stop taking Rosuvastatin tablets and talk to your doctor immediately if you have any unusual aches or pains in your muscles which go on for longer than expected

Lupus-like disease syndrome (including rash, joint disorders and effects on blood cells).

 Advice to 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 exercise caution when dispensing the product and where possible, provide an updated PIL. The updated PILs are available via the MHRA website:

Rosuvastatin 5 mg film-coated tablets-PIL

Rosuvastatin10 mg film-coated tablets-PIL

Rosuvastatin 20 mg film-coated tablets-PIL

Rosuvastatin 40 mg film-coated tablets-PIL

Accord Healthcare Limited have confirmed that all future batches will contain the updated PIL and that upon request they will be 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

Company contacts for further information

For more information or medical information queries please contact: Accord Medical Information Department on 01271 385257, email medinfo@accord-healthcare.com.

For stock control queries, please contact: Accord Customer Services Team on 0800 373573

For updated PIL requests please contact contact@accord-healthcare.com or phone: 01271 385200

Access the full recall