All Ultrasound Gel and Lotion Products Manufactured by Canadian Company Recalled Due to Microbial Contamination Concerns

All ultrasound gels and lotions manufactured by a Canadian pharmaceutical company have been recalled due to risk of bacterial contamination. The gels and lotions were distributed to the United States, Canada, and several other countries. The products, sold under various brand names, have been associated with at least 66 infections, including 60 bloodstream infections caused by an unknown source of Burkholderia cepacia complex (Bcc).

The U.S. Food & Drug Administration (FDA) is working to ensure that healthcare providers, healthcare facility risk managers, and procurement staff are notified to immediately stop using and discard all ultrasound gel and lotion products manufactured by this company. The FDA is classifying the recall as Class I due to the high level of risk posed by contaminated product. According to the announcement posted by the FDA, the effects of Bcc range from no symptoms to serious infections, including bloodstream infections that may result in sepsis or death.

Burkholderia cepacia complex (Bcc) is the name for a group of bacteria that can be found in soil and water according to the Centers for Disease Control and Prevention (CDC). The bacteria typically pose little medical risk to healthy people, but people who have certain health problems may be more susceptible to infections according to the agency. Bcc can be resistant to common antibiotics making potentially contaminated products used in healthcare environments of particular concern.

The dedicated scientists at MPL Laboratories provide testing services to help identify contamination and sterility issues. MPL Laboratories provides testing services for USP 60 Microbiological Examination of Nonsterile Products – Tests for Burkholderia Cepacia Complex. Their testing experts operate an FDA and DEA registered facility that offers cGMP and ISO 17025 compliant microbiology testing of pharmaceuticals, cosmetics, personal care products, OTC medicines, and consumer goods. These services are available to manufacturers, importers, distributors, regulatory agencies, and healthcare providers.

To learn more about microbial or other product testing services provided by MPL Laboratories, please visit www.MPLLaboratories.com, call (800) 548-1874, or email  info@MPLLaboratories.com .


About MPL Laboratories
MPL Laboratories (formerly Marypaul Laboratories) was founded in 1985 as a full-service microbiology laboratory. It is cGMP compliant, FDA and DEA registered, ISO/IEC 17025 accredited by PJLA, and NJDEP certified. MPL’s staff includes M.S. and B.S. degreed microbiologists and other dedicated scientists. The microbiology testing laboratory serves the pharmaceutical, cosmetic, personal care and food industries. MPL aims to provide its clients with high quality, reliable test data in a timely manner. The laboratory is part of the EMSL Analytical, Inc. network of laboratories across the United States and Canada.

Contact Information

Joseph Frasca

Senior Vice President of Marketing

MPL Laboratories

(1) 856-303-2503

Contact via E-mail