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Pharmacists warned about information errors in Rosuvastatin batches

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Pharmacists warned about information errors in Rosuvastatin batches

The Medicines and products Regulatory Agency has warned pharmacists that some batches of Rosuvastatin products contain patient information leaflets that have errors.

Rosuvastatin 5mg (batch number P2102389), 10mg (P2103803) and 20mg (P2104132) film-coated tablets, manufactured by Accord Healthcare, have leaflets that do not include the most up-to-date safety information.

Accord confirmed to the MHRA that the problem affects 29,086 packs across the three batches. Accord also said all other packs of those batches that it is holding will not be distributed.

The MHRA said the missing information related to the section about what patients should do if they are taking other medicines and the possible side-effects.

The MHRA said the batches were not being recalled because there was no risk to the product’s quality but urged pharmacists to “exercise caution when dispensing the product and where possible, provide an updated PIL".

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