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 |
|---|---|---|---|
| P2102389 | 03/2023 | 28 | 24-06-2022 |
Rosuvastatin 10 mg film-coated tablets PL 20075/0403
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| P2103803 | 04/2023 | 28 | 28-06-2022 |
Rosuvastatin 20 mg film-coated tablets PL 20075/0404
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| P2104132 | 05/2023 | 28 | 28-06-2022 |
Active Pharmaceutical Ingredient: Rosuvastatin calcium
Brief description of the problem
Further to a previous defect notification, EL (21)/A21 Accord Healthcare have informed us of an error with the patient information leaflets (PILs) that have been packaged in the above additional batches of products. These were an older version of the PIL which did not include the most up to date safety information.
Accord Healthcare have confirmed that this issue impacts 29086 packs across the three different batches mentioned. The MHRA have confirmed with Accord Healthcare that all other packs of the above batches currently on hold at the manufacturer will not be distributed.
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 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 exercise caution when dispensing the product and where possible, provide an updated PIL. The updated PIL is 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
Accord Healthcare Limited have 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.
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