FDA Issues Alert - Pharma Manufacturers–Crospovidone - Excessive Levels of Peroxide From China Based Manufacturer Found
Posted Oct 23 2010 1:36pm
Here’s one more warning on quality for the Chinese pharmaceutical manufacturers with more than the allowed levels found in a very common ingredient used with drug and dietary supplements. The FDA states it doesn’t see this as having any health issues up front; however, if used in this current form, the potency of some drugs could suffer.
Drug manufacturers who use or have used the ingredient with manufacturing are requested to contact the FDA. BD
FDA issued an alert today that it has detected “excessive levels of peroxide in one lot of Crospovidone (cross linked polyvinyl N-pyrrolidone) manufactured by China-based Tianjin Boai NKY International Ltd.” Although there have not been any related adverse-event reports to date and although the level of peroxide found does not pose a major health risk, said the agency in an advisory statement yesterday, there is concern that elevated levels of peroxide can cause “subpotent finished products.”
In fact, the peroxide level found by FDA in the lot was more than four times the maximum level of peroxide (400 ppm) that is recommended in compendial monographs. This particular ingredient, crospovidone, is very common in drugs and dietary supplements.