News / Press Release
Tuesday, 29th April 2025
Recall of pms-Fluoxetine Cap 10mg & pms-Fluoxetine Cap 20mg
The Department of Health (DH) today (29th Apr 2025) endorsed Trenton-BOMA Limited (T-BOMA), to voluntarily recall six batches of pms-Fluoxetine Cap 10mg and two batches of pms-Fluoxetine Cap 20mg from the market as a precautionary measure due to the nitrosamine result above the interim limit for the Canadian market.
Name of Products:
pms-Fluoxetine Cap 10mg & pms-Fluoxetine Cap 20mg
HK Registration Number:
HK-61931 & HK-59714
Batch Number (expiry date):
pms-Fluoxetine Cap 10mg:
643518 (31/07/2025)
644912 (30/09/2025)
647317 (31/12/2025)
648682 (31/05/2026)
653478 (28/02/2027)
655449 (30/04/2027)
pms-Fluoxetine Cap 20mg:
641413 (30/04/2025)
645412 (31/08/2025)
The above products, containing fluoxetine hydrochloride, is a prescription medicine indicated for the treatment of depression. The above batches of products have been imported into Hong Kong and supplied to the private doctors, pharmacies, private hospitals and veterinary.
T-BOMA has set up a dedicated Recall hotline (852-8101 2716) to handle related enquiries.
So far, T-BOMA has not received any adverse reaction reports in connection with the impacted batches. T-BOMA will closely monitor the recall and report to DH as appropriate.
Recall of pms-Fluoxetine Cap 10mg & pms-Fluoxetine Cap 20mg
The Department of Health (DH) today (29th Apr 2025) endorsed Trenton-BOMA Limited (T-BOMA), to voluntarily recall six batches of pms-Fluoxetine Cap 10mg and two batches of pms-Fluoxetine Cap 20mg from the market as a precautionary measure due to the nitrosamine result above the interim limit for the Canadian market.
Name of Products:
pms-Fluoxetine Cap 10mg & pms-Fluoxetine Cap 20mg
HK Registration Number:
HK-61931 & HK-59714
Batch Number (expiry date):
pms-Fluoxetine Cap 10mg:
643518 (31/07/2025)
644912 (30/09/2025)
647317 (31/12/2025)
648682 (31/05/2026)
653478 (28/02/2027)
655449 (30/04/2027)
pms-Fluoxetine Cap 20mg:
641413 (30/04/2025)
645412 (31/08/2025)
The above products, containing fluoxetine hydrochloride, is a prescription medicine indicated for the treatment of depression. The above batches of products have been imported into Hong Kong and supplied to the private doctors, pharmacies, private hospitals and veterinary.
T-BOMA has set up a dedicated Recall hotline (852-8101 2716) to handle related enquiries.
So far, T-BOMA has not received any adverse reaction reports in connection with the impacted batches. T-BOMA will closely monitor the recall and report to DH as appropriate.