CSL Behring announced an extension to its voluntary recall of two lots of Helixate FS (antihemophilic factor [recombinant], formulated with sucrose with vial adapter), which is indicated for the treatment of hemophilia A. CSL Behring previously announced a voluntary recall on July 25, 2016, due to stability testing that revealed a loss of potency to below pre-specified acceptable levels for the following lots:
- Lot # 270TN1G
- Lot # 270R979
The extension of the recall was prompted by an analysis of additional lots manufactured before November 2015. Routine stability testing again identified declining potency issues as the problem. Two lots that fell below the acceptable range were:
- 2000 IU Lot # 270PWG6 Expiry Date: 05/08/2017
- 1000 IU Lot # 270NV9G Expiry Date: 09/23/2016
Based on all currently available and reviewed data, no safety relevant observations or signals have been detected, though additional lots may be subject to recall.
The company noted that the issue was not related to the product’s safety, and any outstanding vials of these two lots could be replaced at no cost by contacting 1-800-683-1288 or [email protected].
Sources: National Hemophilia Foundation, July 25, 2016; National Hemophilia Foundation, August 11, 2016.