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).
US Heparin maker Scientific Protein Laboratories (SPL) says it has resolved “many of the issues” addressed in the US Food and Drug Administration (FDA) warning letter it received late last month.
Regulatory enforcement efforts to tackle counterfeit and substandard APIs are in disarray, according to Guy Villax, CEO of Hovione, who spoke at AAPS about the scale of the problem.
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.
US Marshals have entered Celsus Laboratories to seize 11 lots of heparin, which contain contaminated material from China according to the US Food and Drug Administration (FDA).
The new guidelines for how monographs will be revised and
elaborated to tackle potentially genotoxic impurities (PGIs) have
been published by the European Pharmacopeia Commission.
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 number of people whose deaths are associated with an allergic
reaction to heparin has shot up as the US Food and Drug
Administration (FDA) has updated its tally.
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
contaminant.
US biopharmaceutical company Scolr, latterly known as Nutraceutix,
is to ship the first order for its patented controlled delivery
product Glucosamine/Chondroitin to Europe.
