Health Canada announces that Pharmascience Inc. is recalling the following products from retailers because the affected lots exceed the interim acceptable limit for N-nitroso-fluoxetine:
- PMS-FLUOXETINE 10mg Capsules (lot number: 644913, 643517, 648104, 646137, 653478, 648683, 648063, 648065, 647542, 641417, 641895, 646134, 644911, 643518, 643213, 645409, 642179, 644912, 642513, 655449, 649562, 648682, 651196, 653477, 648067, 647317, 645496, 646133, 645498, 646135, 648066)
- PMS-FLUOXETINE 20mg Capsules (lot number: 644549, 645412, 642182, 641413)
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-affected-lots-exceed-interim-acceptable-limit-n-nitroso-fluoxetine
In Hong Kong, PMS-Fluoxetine Capsules 10mg (HK-61931) and PMS-Fluoxetine Cap 20mg (HK-59714) are pharmaceutical products registered by Trenton-Boma Ltd (T-Boma). Both products are prescription-only medicines. On 29 April 2025, the Department of Health (DH) endorsed T-Boma to recall six 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 will be posted on the Drug Office website.
Ends/Tuesday, Apr 29, 2025
Issued at HKT 18:15
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