High levels of peroxide detected in one lot
The U.S. Food and Drug Administration (FDA) alerted drug and dietary supplement manufacturers, compounding pharmacies, and distributors that it had detected excessive levels of peroxide in one lot of crospovidone manufactured by Tianjin Boai NKY International Ltd, of Tianjin, China.
The peroxide level detected in the lot was more than four times greater than the maximum level (440 parts per million) allowed by compendial monographs, according to an FDA advisory released Oct. 21.
The importer has been fully cooperating with FDA and is in discussions with their supplier regarding removal of peroxide during the manufacturing process. The importer has informed us that the objectionable lot has not been used in the manufacture of any drug product for U.S. distribution, an FDA spokeswoman said in an e-mail to PFQ.
The FDA issued an import alert to prevent the entry of any more crospovidone from Tianjin Boai into the U.S., according to the advisory. No illnesses stemming from the imported crospovidone have been reported, and our current review of this issue indicates that adverse events associated with high peroxide-containing crospovidone are unlikely, the FDA spokeswoman said.
The spokeswoman said the FDA is advising companies to implement peroxide testing of povidone analogs as part of their broader vendor qualification programs and to test any potentially affected drug products.
The importer has informed us that the objectionable lot has not been used in the manufacture of any drug product for U.S. distribution.
U.S. Food and Drug Administration spokeswoman
SOURCE:Pharmaceutical Formulation and Quality
