FDA orders imported eye drops recalled due to particulate detection

Two batches of imported eye drops have been ordered recalled due to the detection of crystal particulates that can cause ocular irritation, Taiwan's Food and Drug Administration (FDA) said Tuesday.

In a statement, the FDA said ikervis 1 mg/mL emulsion eye drops containing the main pharmaceutical ingredient ciclosporin have been found to form crystal particulates during stability monitoring.

Ciclosporin is a calcineurin inhibitor used to treat a number of autoimmune and inflammatory conditions, and according to the FDA, is also used as eye drops for keratoconjunctivitis sicca (dry eyes).

The two batches -- 8K38N and 8L29H -- of the ikervis eye drops from French pharmaceutical firm Excelvision were imported by Taiwan Santen Pharmaceutical Co.

The batches, consisting of roughly 110,000 vials, must be fully withdrawn from the market by Dec. 8, said Hung Kuo-teng (???), head of the FDA's Medicinal Products Division.

Hung said the FDA was made aware after the importer recently received notification from the manufacturer of the condition observed in several of their retained samples.

When crystallization forms in the eye drops, it can cause discomfort and irritation when applied, he said, adding that healthcare professionals and pharmacies must stop prescribing the eye drops with immediate effect.

According to the FDA official, the French company has launched an investigation into the root cause of the problem and the recall will not affect patients as there are other medicine types currently covered by the National Health Insurance program.

Source: Focus Taiwan News Channel