Glucient XR Extended-release tablet 500 mg and Meijumet Prolonged Release Tablet 750mg and 1000mg
Consumer-level recall of three metformin products found to contain trace amounts of N-Nitrosodimethylamine (NDMA).
|Date of recall:
||4 December 2019
- Glucient XR Extended-release tablet 500 mg
- Meijumet Prolonged Release Tablet 750mg
- Meijumet Prolonged Release Tablet 1000mg
|| Therapeutic product
- Glucient XR Extended-release tablet 500 mg – One batch: 2881382
- Meijumet Prolonged Release Tablet 750mg – All batches
- Meijumet Prolonged Release Tablet 1000mg – All batches
|Class of Recall:
|Level of Recall:
- Glucient XR Extended-release tablet 500 mg – Glorious Dexa Singapore
- Meijumet Prolonged Release Tablet 750mg – Pharmazen Medicals Pte Ltd
- Meijumet Prolonged Release Tablet 1000mg – Pharmazen Medicals Pte Ltd
|Description of Issue:
||HSA has detected above three metformin products to contain trace amounts of NDMA beyond the internationally acceptable level. However, the potential risks to patients who have been taking the three affected metformin medicines is very low. The recall is conducted as a precautionary measure.
HSA has tested all metformin products marketed in Singapore. Besides the above three products being recalled, the other 43 metformin medicines are not affected.
Metformin is used for the treatment of type 2 diabetes mellitus, particularly in overweight patients, when dietary management and exercise are unable to achieve adequate glycaemic control.
NDMA is a type of nitrosamine impurity that can be found in food or the environment. They are commonly found in low levels in processed food (pickled vegetables, salted fish, processed meat products such as bacon and sausages) and in air pollution. Nitrosamine impurities have recently also been found to be formed unexpectedly during the manufacture of some medicines. Recalls had been undertaken worldwide for affected products found to contain these impurities above the acceptable levels. Acceptable levels of nitrosamines are set in nanograms (ng), i.e., one billionth of a gram, and is based on what is considered as reasonably safe if a patient continues to take the affected medicine every day for a lifetime of 70 years. The additional risk posed by NDMA from metformin, at the levels detected, is considered very low.
Consumers taking the affected metformin medicines are advised not to stop the treatment on their own. The sudden stopping of medicines will raise blood sugar levels, which may pose a greater health risk than the trace amounts of NDMA in the affected medicines. Patients should consult their doctor or pharmacist if any concerns relating to the current treatment.
Doctors, healthcare professionals:
Doctors and healthcare professionals are advised to contact the patients who are taking the affected medicines to arrange for an exchange of their medicines as soon as practicable.
Hospitals, clinics, pharmacies:
The hospitals, clinics, pharmacies of the affected medicines should stop supplying the affected batches and return the remaining stocks to the company.
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.