The Department of Health (DH) today (March 18) instructed three licensed wholesalers, namely Hui Tai Pharmaceuticals Co. Ltd, Sino-Asia Pharmaceutical Supplies Ltd and United Italian Corporation (HK) Ltd, to recall 12 batches of Concentrated Sodium Chloride Injection, USP 23.4% because of visible particulates found in the product. The batches under recall are listed in the Annex.
The recall follows the US Food and Drug Administration (FDA)'s initiative of yesterday when they detected that some of the vials of the said product exhibit translucent visible particles, consistent with glass delamination. Indeed, glass delamination can occur with high pH solutions when the surface glass from the vial separates into thin layers, resulting in glass particles with a flaky appearance. Potential adverse events after intravenous administration of the problematic product include damage to blood vessels in the lung, localised swelling and granuloma formation.
In US, the above product is distributed by a company called American Regent. The product is indicated as an additive in parenteral fluid therapy for use in patients who have special problems of sodium electrolyte intake or excretion. The US FDA is now recalling 21 batches of the product from the US market.
In Hong Kong, there is no record of American Regent's Concentrated Sodium Chloride Injection, USP 23.4% having registered with the Pharmacy and Poisons Board. However, record does show that 12 of the 21 affected batches have been imported via the above three named companies for supply to the Hospital Authority and three private hospitals for the treatment of particular named patients. No adverse event related to the product has been received by DH so far.
The three Hong Kong wholesalers have set up hotlines for enquiry, respectively, Hui Tai Pharmaceuticals Co. Ltd (2570 1899), Sino-Asia Pharmaceutical Supplies Ltd (2573 1400) and United Italian Corporation (HK) Ltd (2887 5175).
Healthcare providers in reception of the affected batches must stop supplying the products further and get in touch with the above suppliers. They are also requested to report related adverse events to the DH.
Members of the public should consult their healthcare providers when in doubt and in particular if they feel unwell after using the product. Attachment：
Annex
(Reprinted from HKSAR Government web page
http://www.info.gov.hk/gia/general/201103/18/P201103180333.htm )