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Recall of proprietary Chinese medicine (pCm) with failed microbial limit (with photo)

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The Department of Health (DH) today (January 10) endorsed the registration holder of the proprietary Chinese medicine (pCm) 【桂枝湯】GUI ZHI TANG (registration number: HKP-06748), Jin Ja Pharmaceutical Co Limited (Jin Ja), to recall from market one of its batches (batch number: CP2010080), as its microbial limit exceeded the limit of the registration criteria set out by the Chinese Medicines Board of the Chinese Medicine Council of Hong Kong (CMCHK).

The recall followed the result of the stability study of GUI ZHI TANG conducted by a private laboratory which was entrusted by Jin Ja. Laboratory result revealed that the sample of GUI ZHI TANG was found to have total aerobic microbial count of 38 000 per gram which was 1.3 times of the registration criteria.

Investigation revealed that the pCm concerned was manufactured in Taiwan and it is indicated for cold, fever and headache. Jin Ja has set up a hotline (2332 5258) to answer related enquiries.

So far, no adverse reports related to the use of the pCm have been received by the DH. DH will closely monitor the recall and samples were collected for further testing. Investigation is ongoing.

Recall of proprietary Chinese medicine (pCm) with failed microbial limit (picture 1)

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