Medicine recalls
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| The United States: Enforcement Report: Recall of Bimatoprost, Alprostadil, Finasteride, Chlorambucil, Latanoprost and Voriconazole |
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The US Food and Drug Administration (FDA) announces that Aspen Biopharma Labs Pvt., Ltd., India is recalling the following products due to cGMP violations:
- Bimatoprost (lot number: HABTC0020123, HABTC0050623, HABTC0091023)
- Alprostadil (lot number: HAALC0020922)
- Finasteride (lot number: HAFSC0040923, HAFSC0050923)
- Chlorambucil (lot number: HACUC0010722, HACUC0010123)
- Latanoprost (lot number: HALAC0010123, HALAC0050923)
- Voriconazole (lot number: HAVZC0020922)
Bimatoprost is used to reduce intra-ocular pressure in the treatment of open-angle glaucoma and ocular hypertension. It is also used in the treatment of hypotrichosis of the eyelashes.
Alprostadil is used mainly in congenital heart disease and in erectile dysfunction.
Finasteride is used in the management of benign prostatic hyperplasia and male-pattern baldness.
Chlorambucil is used in the treatment of chronic lymphocytic leukaemia and lymphomas, including Hodgkin's disease. It is also used in Waldenstrom's macroglobulinaemia and has been given in gestational trophoblastic tumours.
Latanoprost is used to reduce intra-ocular pressure in patients with open-angle glaucoma and ocular hypertension.
Voriconazole is used mainly in immunocompromised patients for the treatment of invasive aspergillosis, candidaemia in non-neutropenic patients, fluconazole-resistant serious invasive candidiasis, oesophageal candidiasis, and serious fungal infections due to Scedosporium and Fusarium spp.
Please refer to the following website in FDA for details:
http://www.accessdata.fda.gov/../index.cfm?Product=212323
http://www.accessdata.fda.gov/../index.cfm?Product=212324
http://www.accessdata.fda.gov/../index.cfm?Product=212325
http://www.accessdata.fda.gov/../index.cfm?Product=212326
http://www.accessdata.fda.gov/../index.cfm?Product=212327
http://www.accessdata.fda.gov/../index.cfm?Product=212328
In Hong Kong, the above active pharmaceutical ingredients are not registered pharmaceutical substances. The affected lots have not been imported by local manufacturers for own manufacturing.
Ends/Wednesday, Mar 19, 2025
Issued at HKT 18:00
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