Medicine recalls
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| The United States: Voluntary Drug Recall Extension - Helixate FS |
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CSL Behring 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 Helixate® FS containing active ingredient manufactured before November 2015. The lots communicated on July 21, 2016 are HELIXATE FS 2000 IU (Lot no.: 270R979 and 270TN1G).
An analysis was conducted 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, CSL Behring 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 Sterile Water for Injection, USP, filter transfer set and package insert.
Products subject to recall include HELIXATE FS 250 IU, 500 IU, 1000 IU, 2000 IU and 3000 IU. Details of the lot numbers involved can be found at the FDA website.
Please refer to the following website in FDA for details:
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/../ucm517460.htm
In Hong Kong, the above products are not registered pharmaceutical products. Related news was previously issued by the MHRA, and was posted on the Drug Office website on 12 August 2016.
Ends/ Tuesday, August 23, 2016
Issued at HKT 13:00
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