MHRA Class 2 Medicines Recall: Ikervis 1 mg/ml eye drops, emulsion and Verkazia 1 mg/ml eye drops, emulsion (SANTEN Oy)

MHRA Class 2 Medicines Recall: Ikervis 1 mg/ml eye drops, emulsion and Verkazia 1 mg/ml eye drops, emulsion (SANTEN Oy)

November 18, 2021

Drug alert number: EL (21)A/30

MDR Number: MDR 268-08/21

Date issued: 18 November 2021

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Class 2 medicines recall for IKERVIS 1 mg/ml eye drops, emulsion and VERKAZIA 1 mg/ml eye drops, emulsion (SANTEN Oy (trading as Santen UK Limited))

Brief description of the problem

SANTEN Oy (trading as Santen UK Limited) are recalling the above batches of products 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.

Following the completion of their investigations SANTEN Oy are recalling the above batches additional to those recalled on 15 September 2021 (Reference EL (21)A/22).

IKERVIS 1 mg/mL eye drops, emulsion, EU/1/15/990/001

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

VERKAZIA 1 mg/mL eye drops, emulsion, EU/1/15/990/002

Batch Number Expiry Date Pack Size First Distributed
1L14P 05/2022 120 x 0.3ml 29 Jan 2021
4L40H 09/2022 120 x 0.3ml 06 May 2021
6L04J 10/2022 120 x 0.3ml 02 Jul 2021

Parallel Import/Distributed products

Orifarm A/S

IKERVIS 1 mg/mL eye drops, emulsion, EU/1/15/990/001

Batch Number Parallel Distributor’s Batch Number Expiry Date
Pack Size First Distributed
6L03F 6L03F 10/2022 30 x 0.3ml 9th December 2020

Advice for healthcare professionals

  • Stop supplying the above batches 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.

Further Information

Santen UK Limited

For more information, please contact +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

Orifarm A/S

For all enquiries please contact:

Paul Tobin (Responsible Person) on 07583577513 or email at paul.tobin@orifarm.com

Steven Cross (UK Parallel Import Sales Manager) on 07498975920 or email at steven.cross@orifarm.com

View alert here.

 



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