Medicine recalls
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| The United States: Enforcement Report: Recall of Neupogen (filgrastim) for injection, 300mcg/1 mL and Neupogen (filgrastim) for injection, 480 mcg/1.6 mL |
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The US Food and Drug Administration (FDA) announces that Amgen, Inc. is recalling the following products because stability data does not support expiry. The products have the potential to be out of specification at the time of expiry of 36-months.
- Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials (lot numbers: 1147300, 1147300A, 1152064, 1154734, 1156806, 1159109, 1163909, 1164631, 1171366, 1182097, 1176114, 1182094)
- Neupogen (filgrastim) For Injection, 480 mcg/1.6 mL (300 mcg/1 mL), 1.6 mL single Dose Vial (lot numbers: 1147308, 1154183, 1156807, 1160222, 1160223, 1163912, 1167352, 1171365, 1175057, 1176250)
Filgrastim is a granulocyte colony-stimulating factor (G-CSF), a haematopoietic growth factor that stimulates the development of granulocytes.
Please refer to the following website in FDA for details:
http://www.accessdata.fda.gov/../index.cfm?Product=212550
http://www.accessdata.fda.gov/../index.cfm?Product=212588
In Hong Kong, Neupogen Inj 0.3mg/ml (HK-35878) is a pharmaceutical product registered by Amgen Hong Kong Limited (Amgen). The product is a prescription-only medicine. Amgen has been contacted regarding the above issue and their reply is pending.
Ends/Saturday, Mar 22, 2025
Issued at HKT 12:00
As confirmed with Amgen Hong Kong Limited, the affected batches have not been imported into Hong Kong.
Content last updated: Tuesday, Mar 25, 2025 |
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