Medicine recalls
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| The United States: Voluntary Drug Recall Extension - Kogenate FS Antihemophilic Factor (Recombinant) |
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Bayer HealthCare LLC is issuing a follow-up to the communication sent to customers on July 21, 2016 regarding a voluntary recall of two lots of hemophilia A drug Kogenate® FS containing active ingredient manufactured before November 2015. The lots communicated on July 21, 2016 are KOGENATE FS 2000 IU VIAL ADAPTER (Lot no.: 270R978 and 270TN1C).
Bayer has conducted an analysis of additional lots with active ingredient manufactured before November 2015 to determine if there was a need for further action. The analysis is now complete and, as a result, Bayer is voluntarily recalling additional lots.
Routine stability testing showed potency is declining faster than expected in these lots, which is why the recall is being conducted. The material is packaged in 5mL glass vials and comes in a shelf carton with either a BIO-SET or vial adapter. Additional lots subject to recall include:
• KOGENATE FS 2000 IU VIAL ADAPTER (Lot no.: 270PWG8)
• KOGENATE FS 3000 IU BIO-SET (Lot no.: 270NPV2)
• KOGENATE FS 250 IU VIAL ADAPTER (Lot no.: 270RV8X and 270TN10)
• KOGENATE FS 500 IU VIAL ADAPTER (Lot no.: 270R70V, 270RJ5L, 270T306 and 270TG7L)
• KOGENATE FS 1000 IU VIAL ADAPTER (Lot no.: 270TWOR)
• KOGENATE FS 3000 IU VIAL ADAPTER (Lot no.: 270TTR6)
Please refer to the following website in FDA for details:
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/../ucm517465.htm
In Hong Kong, Kogenate FS for Inj 250IU (HK-54068), 500IU (HK-54069) and 1000IU (HK-54067) are pharmaceutical products registered by Bayer Healthcare Ltd (Bayer), and are prescription only medicines. Kogenate FS 2000IU and 3000IU are not registered. So far, the Department of Health has not received any adverse drug reaction report related to the products. Related news was previously issued by the Health Canada, MHRA and Taiwan FDA, and was posted on the Drug Office website on 28 July, 12 August and 19 August 2016 respectively. As confirmed with Bayer, the above products have never been marketed in Hong Kong.
Ends/ Tuesday, August 23, 2016
Issued at HKT 13:00
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