Stability testing has uncovered particle contamination in Halozyme's Hylenex recombinant, a fluid absorption drug, leading to a voluntary recall of all lots, some 3,500 vials in total. The contamination is described as "small, flake-like particles identified as glass," according to an announcement.
No such contamination was found at product release, according to Baxter, which markets and sells the pediatric rehydration product under license from Halozyme.
Halozyme says that because of the recall, Baxter has not held up its end of their agreement. In addition to the license, Baxter provides fill/finish services. Halozyme says it may terminate the agreement if Baxter is unable to resolve the manufacturing issues within 120 days.
- see the Baxter announcement
- here's the Halozyme release
- see the Reuters item