Hong Kong (HKSAR) - The Department of Health (DH) today (August 8) instructed licensed manufacturer, Quality Pharmaceutical Laboratory Ltd. (Quality) to recall all batches of Antacaine Suspension 3600ml (Antacaine)(registration number: HK-23691) from the market because of quality issue.
During a recent Good Manufacturing Practice inspection, the pH result of a stability test of a batch of the product was found higher than the specification. Further samples were taken from the samples retained by the manufacturer and subsequently the pH of some of these samples were also higher than specification.
However, the increase in pH would not affect the safety and efficacy of the product.As a precautionary measure, DH instructs Quality to recall all batches of the product.
Quality has manufactured a total of 279 bottles of the product since June 2011.The products have been supplied mainly to private doctors, two private hospitals, two veterinary clinics and some pharmacies in Hong Kong.
The DH's investigation is continuing.
Antacaine is indicated for relief of heartburn and indigestion.
It can only be sold under the supervision of pharmacists at registered dispensaries.
The DH has not received any adverse report in connection with the product.
Quality has set up a hotline at 2429 8412 to answer related enquiries. DH will closely monitor the recall.
"Here, contravention of the Public Health and Municipal Services Ordinance (Cap 132), selling a drug not of the nature, substance or quality demanded by the purchaser, might have occurred. The maximum penalty involved is a fine of $10,000 and three months' imprisonment.
The DH will seek the Department of Justice's advice on completion of our investigation," the spokesman said.
"Members of the public who have consumed the product should consult their health-care providers if in doubt or feeling unwell," the DH spokesman said.
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