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Sep 01, 2023

Class 2 Medicines Recall: Novartis Pharmaceuticals UK, Sandimmun Oral Solution, EL(22)A/40

Novartis Pharmaceuticals UK are recalling a batch of Sandimmun Oral Solution due to the presence of crystals in the solution. MDR 050-09/22 Novartis Pharmaceuticals UK Sandimmun Oral Solution PL

Novartis Pharmaceuticals UK are recalling a batch of Sandimmun Oral Solution due to the presence of crystals in the solution.

MDR 050-09/22

Novartis Pharmaceuticals UK

Sandimmun Oral Solution PL 00101/0124

Active Pharmaceutical Ingredient: ciclosporin

Novartis Pharmaceuticals UK are recalling the above batch due to the presence of crystals in the solution. The crystals have been identified as the active substance (ciclosporin). The presence of crystals has been observed in some finished product packs marketed in other countries that share the same master batch as the UK batch above. Therefore, this UK batch is recalled as a precautionary measure. Novartis Pharmaceuticals UK have confirmed no other batches of the product are impacted.

Stop supplying the above batch immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.

For more information, medical or supply enquiries, please contact 01276 698370, or email [email protected]

Recipients of this Medicines Recall 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 Centre10 South ColonnadeCanary WharfLondonE14 4PU

Telephone +44 (0)20 3080 6574

[email protected]

Class 2 Medicines Recall: Novartis Pharmaceuticals UK, Sandimmun Oral Solution, EL(22)A/40