All ultrasound gels and lotions manufactured by a Canadian company recalled due to microbial contamination concerns
MPL provides sterility testing and microbial testing services for pharmaceuticals, cosmetics, personal care products, over-the-counter drugs, and consumer goods at its FDA, cGMP and ISO registered test center. 17025.
All ultrasound gels and lotions manufactured by a Canadian pharmaceutical company have been recalled due to the risk of bacterial contamination. The gels and lotions have been distributed in the United States, Canada and several other countries. The products, sold under various brands, have been linked to at least 66 infections, including 60 blood infections caused by an unknown source of Burkholderia cepacia complex (Bcc).
The United States Food & Drug Administration (FDA) works to ensure that healthcare providers, healthcare facility risk managers, and procurement personnel are warned to immediately stop using and throw away all ultrasound gels and lotions manufactured by this company. The FDA is classifying the recall as Class I due to the high level of risk posed by the contaminated product. According to the FDA announcement, the effects of Bcc range from the absence of symptoms to serious infections, including blood infections that can lead to sepsis or death.
Burkholderia cepacia complex (Bcc) is the name of a group of bacteria that can be found in soil and water according to the Centers for Disease Control and Prevention (CDC). Bacteria generally pose little medical risk to healthy people, but people with certain health conditions may be more susceptible to infections, the agency said. Bcc can be resistant to common antibiotics, making potentially contaminated products used in healthcare settings of particular concern.
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 non-sterile 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, over-the-counter drugs, and consumer goods. These services are available to manufacturers, importers, distributors, regulators, and healthcare providers.
To learn more about microbial testing services or other products provided by MPL Laboratories, please visit www.MPLLaboratories.com, call (800) 548-1874, or e-mail [email protected]
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 microbiologists with MS and BS degrees and other dedicated scientists. The microbiological analysis laboratory serves the pharmaceutical, cosmetic, personal care and food industries. MPL aims to provide its customers with reliable, high-quality test data in a timely manner. The laboratory is part of the EMSL Analytical, Inc. laboratory network across the United States and Canada.
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- MPL Laboratories
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