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Accord rosuvastatin alert

Out of date PIL alert

August 18th 2022

Tagged: MHRA alert

By MHRA

Accord Healthcare Limited has issued an alert relating to three batches of rosuvastatin 5 mg film-coated tablets.

The affected batches are:

Batch NumberExpiry DatePack SizeFirst Distributed
P210238903/20232824-06-2022

Rosuvastatin 10 mg film-coated tablets PL 20075/0403

Batch NumberExpiry DatePack SizeFirst Distributed
P210380304/20232828-06-2022

Rosuvastatin 20 mg film-coated tablets PL 20075/0404

Batch NumberExpiry DatePack SizeFirst Distributed
P210413205/20232828-06-2022

Affected batches contain 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 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).

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