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Baxter International has recalled a drug used to rehydrate children and babies after “flake-like glass particles” were found in vials of the substance.
Halozyme Therapeutics (HT), the company’s partner, accused Baxter of “manufacturing failures” in its handling of Hylenex, issuing a notice of breach of contract.
HT has the right to terminate the relationship between the two firms if the issue is not resolved within 120 days.
A spokeswoman said both companies were working with the US Food and Drug Administration to ensure patient safety, adding that the vials had passed all necessary tests before being shipped out.
“We have no reason to believe there was a breach of the agreement by Baxter,” she explained.
No medical problems have been reported with the drug so far.
The recall is the latest in a series of setbacks that have dented the reputation of Baxter in recent years.
Copyright Press Association 2010
Baxter
Halozyme Therapeutics