Other safety alerts
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| The United States: FDA updates on 2017 Burkholderia cepacia contamination. FDA lab findings again link Rugby Diocto oral liquid docusate sodium to B. cepacia infections |
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The United States (US) Food and Drug Administration (FDA) announces an update on the news on Burkholderia cepacia contamination 2017. FDA testing has identified Burkholderia cepacia in several bottles of Rugby Diocto (docusate sodium) oral liquid from lot No. 20351701 manufactured by PharmaTech LLC, Davie, Florida. This lot was collected by FDA in response to a 2017 multistate outbreak of B. cepacia complex (BCC) bacterial infections that has affected at least eight patients in California and Maryland. Laboratory evidence from FDA and CDC indicates that PharmaTech’s docusate sodium product is the source of the BCC infections.
An outbreak in 2016 included serious infections in 63 confirmed cases and 45 suspected cases in 12 states. These 2016 infections were also linked to contaminated product made by PharmaTech, as confirmed by CDC and FDA testing. An FDA investigation associated with the 2016 multistate outbreak identified BCC in more than 10 lots of oral liquid docusate sodium manufactured by PharmaTech. The 2016 investigation also detected BCC in the water system used to manufacture the product.
Additional bacteria, yeast, and mold contaminants were also found in the PharmaTech docusate sodium oral liquid samples recently tested by FDA. FDA reminds manufacturers about the importance of robust current good manufacturing practices and testing for all non-sterile liquid products, including docusate sodium, to ensure that their products conform to appropriate microbial limits and are free of any microorganisms that may cause infections.
FDA reminds health care professionals and patients not to use any liquid product manufactured by PharmaTech’s Davie, Florida, facility. These products are labeled by a variety of companies, including Rugby, Leader, Major, Centurion, and Mid Valley, and they should not be used due to the possibility of B. cepacia contamination and the potential for severe infections in patients.
Please refer to the following website in FDA for details:http://www.fda.gov/Drugs/DrugSafety/ucm570672.htm
In Hong Kong, there is no registered pharmaceutical product manufactured by PharmaTech LLC, Rugby Laboratories, Leader Brand, Major Pharmaceuticals, Centurion Labs, Vilvet, Bayshore, Metron, Virtus and Mid Valley. Related news was previously issued by US FDA and Macau Health Bureau, and was posted on the Drug Office website since 16 July 2016, with the latest update posted on 31 August 2017.
Ends/Monday, October 30, 2017
Issued at HKT 17:45
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