Debridat for Oral Suspension 250ml
Retail-level recall of Debridat for Oral Suspension 250ml due to low probability of the product containing a foreign material.
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Date:
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22 November 2019
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Product:
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Debridat For Oral Suspension 250ml
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Active Ingredient:
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Trimebutine
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Product Category:
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Therapeutic product
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Batch No.:
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3835
3874
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Class of Recall:
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2
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Level of Recall:
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Retail
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Local Company:
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Pfizer Pte. Ltd.
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Description of Issue:
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The company found the affected batches to have a low probability of containing a foreign material. The estimated possibility of finding the foreign material in a bottle of Debridat Oral Suspension is very small (0.0001%). No defect has been reported related to this issue for any batches that have been distributed. However, as a precautionary measure, the company is voluntarily recalling the products from the market.
Debridat Oral Suspension is a prescription medicine used to treat the symptoms of irritable bowel syndrome or digestive disorders such as abdominal pain and cramps, spasms, flatulence, diarrhoea and/or constipation. There are alternative treatments available for patients.
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Recall Instructions
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Hospitals, clinics, pharmacies:
Stop supplying the affected batches and return the remaining stocks to the company.
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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.
Consumer, Healthcare professional, Industry member, Therapeutic Products
Published:
Product Recalls