Recall of "ChloraPrep One-Step 3ml Applicator - Clear"

24 July 2020
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The Department of Health (DH) today (July 24) endorsed a licensed wholesale dealer Becton Dickinson Asia Limited (BD) to recall all batches of "ChloraPrep One-Step 3ml Applicator - Clear" from the market due to potential growth of a fungus.
 
The DH received notification from BD this evening that the company is recalling the above-mentioned product because they have found that if the product is stored at 30 degree Celsius and 75 per cent relative humidity for more than six months, there may be growth of a fungus Aspergillus penicillioides due to a breach in the package integrity. The contaminated applicator may affect patient’s safety during invasive procedure.
 
"ChloraPrep One-Step 3ml Applicator - Clear", containing chlorhexidine and isopropyl alcohol, is used for patient preoperative skin preparation. The product is not registered in Hong Kong. In order to tighten the control of chlorhexidine-containing products, with effect from July 8, 2020, skin antiseptics containing chlorhexidine are generally considered as pharmaceutical product requiring registration.
 
The product was distributed by United Italian Corporation (H.K.) Ltd. According to the distributor, the product had been supplied to the Hospital Authority, private hospitals and local doctors before this July. So far, the DH has not received any adverse event against the product, and will closely monitor the recall.
 
 BD has set up a hotline (2575 8668) to answer related enquiries.
 
Members of the public who have used the product should consult their healthcare professional if in doubt.

Reposted from HKSAR Government webpage:
https://www.info.gov.hk/gia/general/202007/24/P2020072400798.htm