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# FDA Investigating B. Cepacia Outbreak
- URL: https://www.fdaweb.com/fda-investigating-b-cepacia-outbreak/
- Published: 2018-05-09T12:00:00.000Z
- Updated: 2026-09-15T00:03:52.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5141399

FDA says there are 10 confirmed cases of infection caused by bacteria within the *Burkholder cepacia* complex in three states: California (2), New Jersey (1), and Pennsylvania (7). An agency [notice](http://s2027422842.t.en25.com/e/es?s=2027422842&e=85231&elqTrackId=B1F0B909CCF90C71B9C490C37BFE6647&elq=acc9211138aa43eeb00269f176140598&elqaid=3461&elqat=1&ref=fdaweb.com) says the patients were already hospitalized for acute conditions and acquired the infections while hospitalized. The infections have been linked to the Medline Remedy Essentials No-Rinse Cleansing Foam produced by Shadow Holdings (known as Bocchi Laboratories), Santa Clarita, CA. The company has recalled three lots of 4 oz and 8 oz bottles of the product that have been identified as positive for *B. cepacia*, FDA says.

The agency says it is investigating the matter further to determine whether any additional products or lots may present a risk to consumers.