Product Recalls
Mitomycin-C Kyowa (Mitomycin-C) 2mg/vial and 10mg/vial injections
Audiences
Consumer
Healthcare professional
Industry member
Product type
Therapeutic Products
16 October 2019
Retail-level recall of Mitomycin-C Kyowa (Mitomycin-C) 2mg/vial and 10mg/vial injections due to concerns that the products' sterility cannot be guaranteed due to manufacturing deviations.
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Recall details
Date of recall: | 16 October 2019 |
|---|---|
Product: | Mitomycin-C Kyowa for Injection 2mg/ vial; |
Active Ingredient: | Mitomycin-C |
Product Category: | Therapeutic product |
Batch No.: | All unexpired batches |
Class of Recall: | 2 |
Level of Recall: | Retail |
Local Company: | Kyowa Kirin Asia Pacific Pte. Ltd. |
Description of Issue: | Due to deviations in the manufacturing processes of the products, the sterility of the products cannot be guaranteed. Based on the company’s testing, all the batches supplied in Singapore had complied with the required specifications, including that for sterility. However, as a precautionary measure, the company is voluntarily recalling the products from the market. Mitomycin-C Kyowa injection is a prescription medicine used in the treatment of various cancers including colorectal cancer, lung cancer, breast cancer and bladder tumour. There are alternative cancer treatments available for patients. Patients who are using the Mitomycin-C Kyowa injections are advised to consult their doctors if they have any concerns relating to the use of the injection. |
Recall Instructions: | Hospitals, clinics, pharmacies: Stop supplying the affected products and return the remaining stocks to the company. |
Note:
The Health Sciences Authority (HSA) publishes information regarding recalls of health products supplied in Singapore. These product recalls may be conducted on a company’s own initiative or upon HSA request to remove products where there are issues with quality, safety or efficacy.
When a recall is initiated, it does not necessarily imply that a product is considered unsafe or is inefficacious. A recall can also be initiated to remove products with quality defects that does not impact safety or efficacy from the market so as to ensure that products registered in Singapore continue to meet the stringent regulatory standards stipulated by HSA.
Not all recalls will lead to press releases. However, when a recall involves a product that has been widely distributed or a product that poses a serious health risk, HSA will issue a press release to inform members of public.
Class of recall
A recall is classified as Class 1 or Class 2 depending on the potential hazard of the issue.
Class 1: For recalls of products with issues that can potentially cause serious adverse health outcomes or death.
Class 2: For recalls of products with issues that would not likely cause serious adverse health outcomes.
Level of recall
The level of product recall will depend on the potential hazard of the affected product, extent of distribution and whether other mitigating measures can be taken to address the issue.
Consumer level: Affected product or batch(es) recalled from patients and consumers as well as wholesale suppliers, retail suppliers, hospitals, clinics and pharmacies.
Retail level: Affected product or batch(es) recalled from retail suppliers, hospitals, clinics and pharmacies as well as wholesale suppliers.
Wholesale level: Affected product or batch(es) recalled from wholesale suppliers.