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The Department of Health (DH) today (May 11) instructed Warwick Trading Co, a licensed wholesaler, to recall from shelves all batches of Maximum Strength Fungicure Liquid 25% (Fungicure) (registration number: HK-58917) as the product may bear an unapproved package insert that would make it an unregistered pharmaceutical product.
A DH spokesman revealed that the matter came to light upon the department's investigation into a public enquiry that the Chinese package insert of Fungicure carried the indication "onychomycosis", which was not found in the English package insert, and this indication was not approved in the registered version.
According to the DH investigation so far, all of the product concerned at Warwick's warehouse was found to contain an unregistered version of the package insert and label. Therefore, Warwick was instructed to recall the product from the market.
The DH's investigation is continuing.
Warwick had so far imported 4,757 boxes, among which 4,109 boxes had been sold to local pharmacies and exported to Macau.
Fungicure, manufactured in the US by Denison Pharmaceuticals Inc, is an over-the-counter medicine containing undecenoic acid for anti-fungal treatment.
"Here, contravention of the Pharmacy and Poisons Ordinance is suspected. The sale and possession of unregistered pharmaceutical products is an offence under the Pharmacy and Poisons Ordinance. The maximum penalty is a fine of $100,000 and two years' imprisonment," the spokesman explained.
Warwick has set up a hotline (2799 8926) for the recall. The DH will monitor the recall.
Ends/Friday, May 11, 2012
Issued at HKT 18:33
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