In brief
On 16 August 2023, the Health Sciences Authority issued two retail-level recalls for batches of Apo-Amitriptyline and Apo-Acyclovir tablets. The recalls were initiated after impurities at levels above acceptable standards were detected.
Key takeaways
- Sellers and suppliers must ensure health products are compliant with applicable healthcare regulations.
- Supplying adulterated therapeutic products can lead to imprisonment for up to three years and/or a fine of up to SGD 100,000 upon conviction.
In more detail
A retail-level recall was initiated for one batch of the Apo-Amitriptyline 10mg tablets, a therapeutic product containing the active ingredient amitriptyline. The impurity, N-nitroso-nortriptyline, was found at levels above the acceptable level.
A further retail-level recall was also issued for two batches of the Apo-Acyclovir 400mg tablets and one batch of Apo-Acyclovir 800mg tablets, therapeutic products with the active ingredient acyclovir. The concern arose from the detection of the impurity N-nitrosodimethylamine, which was found at levels above the acceptable level.
Hospitals, clinics and/or pharmacies have been instructed to stop supplying the affected batches of such products and to return the remaining stocks to the distributor.
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