Medicine recalls
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| Canada: Recall: Eprex Products |
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Janssen Inc. is recalling certain lots of Eprex products containing Epoetin Alfa 1000 Unit / 0.5 mL as oxidized methionine impurity level may not remain within registered specification throughout shelf-life.
The affected products have been distributed to wholesalers and retailers. Details of the lot numbers involved is as follows:
A. Eprex Sterile Solution 1000 IU / 0.5 mL (lot no.: ECS1Q00 and ECS1Q01)
B. Eprex Sterile Solution 2000 IU / 0.5 mL (lot no.: EBS3P00, EES4I00 and EHS4W00)
C. Eprex Sterile Solution 3000 IU / 0.3 mL (lot no.: ECS2700)
D. Eprex Sterile Solution 4000 IU / 0.4 mL (lot no.: EDS5X00, EAS2X00, EAS4300, EBS2T00 and EBS5C00)
E. Eprex Sterile Solution 6000 IU / 0.6 mL (lot no.: EAS4200 and EJS4R00)
F. Eprex Sterile Solution 8000 IU / 0.8 mL (lot no.: ECS3600, EGS6N00, EGS6N01 and EHS4U00)
G. Eprex Sterile Solution 10000 IU / 1.0 mL (lot no.: EKS5N00)
Health Canada classified the hazard level of the recall as Type II, i.e. a situation in which the use of, or exposure to, a product may cause temporary adverse health consequences or where the probability of serious adverse health consequences is remote.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../53483r-eng.php
In Hong Kong, there are nine Eprex products registered by Johnson & Johnson (Hong Kong) Ltd (J&J). All products are prescription-only medicines. J&J has already notified the Department of Health (DH) of the incident, and the DH has endorsed J&J to voluntarily recall 5 batches of Eprex 1000 Prefilled Syringe 1000iu/0.5ml (HK-39774) (lot no.: EBS4F00), Eprex 4000 Prefilled Syringe 4000iu/0.4ml (HK-39776) (lot no.: EAS4300, EBS5C00 and EJS6Q00) and Eprex 5000 Prefilled Syringe 5000iu/0.5ml (HK-49846) (lot no.: EAS4100) that had been supplied locally from wholesalers on 18 May 2015. Related news has been posted on the Drug Office website on the same day. J&J confirmed that apart from products of the above mentioned affected lot numbers, the others with various strength and affected lot numbers listed in Health Canada's announcement have not been imported into Hong Kong. So far, the DH has not received any adverse drug reaction reports related to the products. The DH will remain vigilant on any safety updates from other overseas regulatory authorities, and will closely monitor the recall.
Ends/ Friday, May 22, 2015
Issued at HKT 15:00
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