PRODUCT RECALL CAUSED BY UNDECLARED GERMANIUM
Product recall notice for Bio-Aquacel Eye Safe
The product Bio-Aquacel Eye Safe is found to be contaminated with an undeclared ingredient (Germanium) that resulted from undeclared tampering of raw material by the supplier who is also the distributor of the product (Tega Kuantum Sdn. Bhd). The device is found to be contaminated with germanium where the effect and safety are not well documented.
Immediately after receiving the news of this contamination, Farmasia is taking several actions as listed below to ensure the product is not being marketed and distributed in the market.
1. Initiated a total product recall from the market (Refer product recall notice);
2. Withdrawn the medical device registration with the Ministry of Health (Refer Medical Device Authority's website portal);
3. Issued Field Safety Notice to all distributors and marketing agents (Refer Field Safety Notice);and
4. Stopped any production and distribution of the product.
In the case where you are one of the consumer to the product, we strongly suggest you to refer to Field Safety Notice here.