FDA Details Contamination Risk for Nonsterile, Water-Based Drugs

The FDA has issued an advisory to drugmakers about the risk of bacterial contamination of nonsterile water-based drug products by Burkholderia cepacian (BCC).

“There is a long history of product recalls due to BCC contamination” traced to deviations from current good manufacturing practice (CGMP) requirements, the agency said, including Sunstar Americas’ Paroex Chlorexidine oral rinse in December 2020 and a series of contaminations in 2016 of an oral solution used to treat intubated children and other immune-compromised patients.

Several antiseptics, such as povidone iodine, benzalkonium chloride and chlorhexidine gluconate, have also been repeatedly recalled in the U.S. and elsewhere due to B. cepacian-based contamination, the agency said.