The agency announced its finding in an advisory last week, warning pharmaceutical manufacturers that the higher than permitted peroxide concentration, which was four times the level allowed by global compendial monographs, may reduce drug efficacy.
And, while no reports of illness or accusations of wrongdoing are linked to the Crospovidone batch, the news will not escape the attention of the numerous US groups that have voiced concerns about the quality of ingredients sourced in China following the high profile problems with heparin and melanine in recent years.
Supplier reliability review
The Food and Drug Administration (FDA) advised that: “Users and distributors implement robust supplier management programmes,” suggesting that reviewing supplier reliability is critical.
It also said drugmakers should analyse samples for peroxide levels, explaining that while no test is listed in Crospovidone monograph the a non-specific USP/EP method can be used to detect levels in excess of 400 ppm.
“Manufacturers who use ingredients that might contain elevated levels of peroxide are advised to notify the FDA if they become aware of any further findings of quality problems or potentially related adverse events.”
TBNI, which is based in the Tianjin Free Trade Zone in Eastern China, may trade as Friends Union Enterprise Boai New Kaiyuan Pharmaceutical, Boai NKY Pharmaceuticals and or Bluetech Chemicals, according to the FDA.
The agency said that: “Other lots of Povidone analogs manufactured by this firm may also contain excessive levels of peroxide. An Import Alert has been issued to prevent further entry of TBNI Crospovidone into the US market.”
The Chinese firm, which specialises manufacturing thiocyanate salts and polyvinylpyrrolidone for both its domestic market and customers worldwide, has not issued a response to the FDA advisory.