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Recall of Apo-Amitriptyline 10mg Tablet
Retail-level recall of one-batch of Apo-Amitriptyline 10mg tablet, due to presence of impurity above the acceptable level.
| Date of recall: | 16 August 2023 |
| Product: | Apo-Amitriptyline 10mg Tablet |
| Active Ingredient: | Amitriptyline |
| Product Category: | Therapeutic product |
| Batch No.: | RM0518 |
| Class of Recall: | 2 |
| Level of Recall: | Retail |
| Local Company: | Pharmaforte Singapore Pte Ltd |
| Description of Issue: | An impurity, N-nitroso-nortriptyline, was found to be above the acceptable level in one batch of Apo-Amitriptyline 10mg Tablet. As a precautionary measure, the affected batch is recalled. |
| Recall Instructions: | Hospitals, clinics, pharmacies to stop supplying the affected batch and return the remaining stocks to the company. |
The Health Sciences Authority (HSA) releases information regarding the withdrawal of health products available in Singapore. These withdrawals can happen either voluntarily by companies or in response to a request from HSA due to concerns about the products’ quality, safety, or effectiveness.
Initiating a withdrawal doesn’t necessarily indicate that a product is unsafe or ineffective. It can also occur to eliminate items with quality issues that don’t affect safety or effectiveness. The purpose is to uphold the high regulatory standards set by HSA for products sold in Singapore.
Not all withdrawals result in official announcements. However, if a withdrawal involves a widely distributed product or one that poses a significant health risk, HSA will issue a press release to inform the general 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.
Link to the full announcement:
https://www.hsa.gov.sg/announcements/product-recall/recall-of-apo-amitriptyline-10mg-tablet
