The FDA agency announced findings in an advisory last week, warning pharmaceutical manufacturers the higher than permitted peroxide concentration, which was four times the level allowed by global compendial monographs, may reduce drug efficacy.
There are no of illness or accusations of wrongdoing as to the Crospovidone batch.
Supplier reliability review
The FDA has said “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.