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| Canada: Recall: PMS-Fluoxetine 10 mg capsule: May exceed the interim acceptable intake limit for N-nitroso-fluoxetine (English only) |
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Health Canada announces that Pharmascience Inc. is recalling 12 lots of PMS-Fluoxetine 10 mg capsule (lot number: 649561, 651195, 651197, 658507, 658508, 658765, 659608, 659875, 660425, 661118, 661412, 661413) from retailers because the affected lots may exceed the interim acceptable intake limit for N-nitroso-fluoxetine.
PMS-FLUOXETINE is indicated for depression, bulimia nervosa and obsessive-compulsive disorder.
Please refer to the following website in Health Canada for details:
http://recalls-rappels.canada.ca/en/alert-recall/pms-fluoxetine-10-mg-capsule-may-exceed-interim-acceptable-intake-limit-n-nitroso
In Hong Kong, PMS-Fluoxetine Capsules 10mg (HK-61931) is a pharmaceutical product registered by Trenton-Boma Ltd (T-Boma). The product is a prescription-only medicine. On 2 Jul 2025, the Department of Health (DH) endorsed T-Boma to recall 4 batches of PMS-Fluoxetine Capsules 10mg (HK-61931) (lot number: 651197, 658508, 660425, 661412) from the market as a precautionary measure due to the presence of impurity in the products. A recall statement will be issued.
Previously on 29 Apr 2025, the DH endorsed T-Boma to recall 6 batches of PMS-Fluoxetine Capsules 10mg (HK-61931) (lot number: 643518, 644912, 647317, 648682, 653478, 655449) and 2 batches of PMS-Fluoxetine Cap 20mg (HK-59714) (lot number: 641413, 645412) from the market as a precautionary measure due to the presence of N-nitroso-fluoxetine in the products. A recall statement was posted on the Drug Office website on the same date. Related news was previously issued by Health Canada and Macao Pharmaceutical Administration Bureau, and was posted on the Drug Office website on 29 Apr 2025 and 30 Apr 2025.
Ends/Wednesday, Jul 2, 2025
Issued at HKT 18:00
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