MHRA Class 2 Medicines Recall: Ikervis 1mg/ml eye drops SANTEN Oy (trading as Santen UK Limited)

MHRA Class 2 Medicines Recall: Ikervis 1mg/ml eye drops SANTEN Oy (trading as Santen UK Limited)

September 15, 2021

Class 2 Medicines recall: Ikervis 1 mg/mL eye drops, emulsion

Drug alert number: EL (21) A/22

Date issued: 8th September 2021

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 2 medicines recall for:

Ikervis 1 mg/mL eye drops, emulsion (Santen UK Limited) EU/1/15/990/001 

SANTEN Oy (trading as Santen UK Limited) are recalling the below batches of product as a precautionary measure due to detection of particles/crystals of the active pharmaceutical ingredient ciclosporin. These particles have been detected following microscopic evaluation during stability monitoring. The company’s root cause investigation is ongoing.

 

Batch Number Expiry Date Pack Size First Distributed
1L49S 05.2022 30 x 0.3ml 09 October 2019
1N80G 02.2023 30 x 0.3ml 08 December 2020

Advice for healthcare professionals

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

The presence of particles may cause ocular irritation, eye pain and foreign body sensation. Whilst the Marketing Authorisation Holder have not received any reports of adverse reactions being caused by the presence of particles in the above batches, healthcare professionals should advise patients to report any suspected adverse reactions via the MHRA Yellow Card Scheme.

Full drug alert can be viewed here.

Company contacts for further information

For more information, please contact Santen UK Limited, Salisbury Hall, St Albans, AL2 1BU, UK at +44 (0)1727 615 110 or email enquiries@santen.co.uk

For medical information queries, please contact 0345 075 4863 or email medinfo@santen.co.uk

For supply queries, please contact AAH Customer services at 0344 561 8899

 



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