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Public Alert No. 006/2022- Public Alert On Class 2 Recall Of IKERVIS 1MG/ML Eye Drops, Emulsion

February 10, 2022,

The National Agency for Food and Drug Administration and Control (NAFDAC) is notifying healthcare providers that Medicines & Healthcare products
Regulatory Agency (MHRA) and the Health Science Authority Singapore is recalling one lot each of IKERVIS 1 mg/mL eye drops manufactured by SANTEN Oy (trading as Santen UK Limited) and Santen Pharmaceutical Asia Pte Ltd.

The recall is a precautionary measure following a detection of particles/crystals of the active pharmaceutical ingredient Ciclosporin A. These particles have been detected following microscopic evaluation during stability monitoring.

Ophthalmic ciclosporin is used to increase tear production in people with dry eye disease. Ciclosporin is in a class of medications called immunomodulators. It works by decreasing swelling in the eye to allow for tear production.

Possible Risk

The presence of particles may cause ocular irritation, eye pain and foreign body sensation. A root cause investigation is ongoing.

Product Details

The details of the affected product are as follows;

 

Product manufacturer Product name Lot number Expiry date Pack size
SANTEN Oy (trading as Santen UK Limited) IKERVIS 1 mg/mL eye drops, emulsion, 4N46E 05/2023 30 x 0.3ML
Santen Pharmaceutical Asia Pte Ltd Ikervis Eye Drops, Emulsion 1mg/ml in a single-dose vial containing 0.3ml 9N20P 30 x 0.3ML

NAFDAC implores importers, distributors, retailers, healthcare providers and consumers to exercise caution in the importation, distribution, sale and use of IKERVIS 1 mg/mL eye drops.

Members of the public if in possession of the recalled lots of the product are implored to discontinue sale or use and handover stock to the nearest NAFDAC office.

NAFDAC encourages healthcare professionals, consumers and patients to report adverse events related to the use of this product to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLLS FREE from all networks) or via pharmacovigilance@nafdac.gov.ng or via the NAFDAC ADR e-Reporting platform available at www.nafdac.gov.ng

NAFDAC……..Customer-focused, Agency-minded!!!

Signed Management

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