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Recall of Chinese medicine granules with failed microbial limit (with photo)
The Department of Health (DH) today (September 28) endorsed a licensed Chinese herbal medicines (Chm) wholesaler, GCM Pharmaceutical Company (GCM), to voluntarily recall single Chinese medicine granules [Boon Cho] (transliteration) Rhizoma Alismatis (Lot No: 202005011 ) and [Boon Cho] (transliteration) Ramulus Cinnamomi (Lot No: 20200510 ) from the market as the total aerobic count of the samples exceeded the microbial limit set out by the Chinese Medicines Board of the Chinese Medicine Council of Hong Kong (CMCHK).
The above-mentioned single Chinese medicine granules were being sampled through the DH's market surveillance. Laboratory results from the DH's Public Health Laboratory Services Branch today revealed that the total aerobic count of the samples of [Boon Cho] (transliteration) Rhizoma Alismatis and [Boon Cho] (transliteration) Ramulus Cinnamomi were found to be 470,000 per gram and 1,300 per gram, which are about 470 times and 1.3 times the maximum limit set out by the CMCHK respectively.
Preliminary investigation revealed that the affected lots of single Chinese medicine granules were manufactured in the Mainland and imported by GCM for solely distribution to local Chinese medicine practitioners (CMP). The DH has instructed GCM to contact relevant CMPs to take appropriate follow up actions and the relevant regulatory authority in the Mainland is being informed.
GCM has set up a hotline (2518 8220) to answer related enquiries. The DH will closely monitor the recall and has obtained other lots of single Chinese medicine granules of the wholesaler for further analysis.
So far, no adverse report related to the use of the two concerned products has been received by the DH. Investigation is ongoing.
According to section 52 of the Public Health and Municipal Services Ordinance (Cap 132), selling any drug not of the nature, substance or quality demanded by the purchaser is liable to a maximum penalty of $10,000 and three months' imprisonment. Upon completion of investigation, the DH will work with the Department of Justice on prosecution matters and will also refer the case to the CMCHK for possible disciplinary action.
Reposted from HKSAR Government webpage: