US drugmaker Baxter International has been ordered to pay compensation of $625,000 to the estate of man who received a dose of heparin that was contaminated with over-sulfated chondroitin sulphate (OSCS).
Baxter International says Pfizer supplied the bulk API used in a batch of Heparin linked to two patient deaths in Delaware, US last week, amid concerns of a repeat of last year’s contamination scandal.
Following fresh criticism of the agency’s handling of the heparin case, in-PharmaTechnologist reports on a FDA official’s explanation of the what, the when and the why of the scandal, from first deaths to continued vigilance.
The decision to end manufacturing operations at its facility in
Morgan Hill, California in the next three years may cost
Hospira up to $35m (€22.7m), according to a document the firm filed
with the US Securities and Exchange Commission...
The US Food and Drug Administration (FDA) has revealed evidence
linking the heparin contaminant with the series of reported adverse
reactions, and has also now issued a warning letter to the Chinese
facility at the centre of the safety...
The heparin recall has widened after a lot of heparin sodium USP
active pharmaceutical ingredient (API) produced by Scientific
Protein Laboratories (SPL) was found to contain a heparin-like