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18 November 2021 by Naresh Rallmil

Class 2 Medicines Recall Ikervis 1mg/ml eye drops, emulsion and Verkazia 1mg/ml eye drops, emulsion

  • Wales
  • England
  • Scotland
  • Northern Ireland

MDR Number: 268-08/21

Company name: SANTEN Oy (trading as Santen UK Limited), Parallel Distributors Orifarm A/S.

Product description and details of the affected batches:

SANTEN Oy (trading as Santen UK Limited)

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

Batch Number

Expiry Date

Pack Size

First Distributed

8K38Q

03/2022

30 x 0.3ml

26 Sep 2019

4L41F

09/2022

30 x 0.3ml

15 Nov 2019

8L28C

11/2022

30 x 0.3ml

17 Sep 2020

  • VERKAZIA 1mg/mL eye drops, emulsion

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 Distributors

Orifarm A/S

  • IKERVIS 1mg/mL eye drops, emulsion

Batch Number

Parallel Distributor’s Batch Number

Expiry Date

Pack Size

First Distributed

6L03F

6L03F

10/2022

30 x 0.3ml

9 Dec 2020

Brief description of 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).

Advice to Healthcare Professionals:

Stop supplying the above batches immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process. EL (21)A/30 Page 2 of 2 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.

Company contacts for 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

To access the full recall:

Class 2 Medicines Recall: SANTEN Oy (trading as Santen UK Ltd) and parallel distributor, IKERVIS 1mg/mL eye drops, emulsion and VERKAZIA 1mg/mL eye drops, emulsion, EL (21)A/30

Drug alert class 2

Drug alert class 2

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