GAN MAI DA ZAO TANG (Herbal International Pty Ltd)
Product Name
GAN MAI DA ZAO TANG
Sponsor
ARTG
326000
Date of review outcome
Date cancellation takes effect
Date of publication
Sep-2024
Outcome
Medicine is no longer permitted to be supplied. Batches 23040015 and 23040011 were recalled by the sponsor due to the label not including a required warning statement.
Is it safe to continue using this medicine?
Yes, based on the sponsor's certification. However, use of this medicine may pose a safety risk for some people. Follow the recommended actions below.
What action should consumers take?
This medicine contains Oyster Shell (Mollusc), which may cause allergic reactions in some people. If you develop a reaction, discontinue use and consult a medical practitioner.
Review scope
Targeted (see Additional Information below)
Information reviewed
ARTG Record, Labels
Issues related to safety
The labels for this medicine were missing the required warning statement for mollusc-derived ingredients. Mollusc-derived ingredients are required to be declared on the labels of medicines as they may cause adverse reactions in individuals with allergies or sensitivities to such substances. However, the affected batches were recalled and are unlikely to pose a further risk to consumers.
Issues related to efficacy
The efficacy of this medicine was not assessed as part of this review
Actions taken during the review
The TGA required the sponsor to correct the issues with this medicine. The sponsor recalled the affected batches of this medicine from the market. The TGA also cancelled this medicine and withdrew permission for further supply due to non-payment of annual charges.
Grounds for cancellation
Cancellation for failure to pay annual charge (paragraph 30(1)(h) of the Act)
Additional information
This medicine was targeted to check its compliance with warning statement requirements related to mollusc-derived ingredients