Topical Anesthetic Gel Recalled Due to Microbial Contamination Concerns
MPL Laboratories provides sterility and microbial testing services for personal care products, pharmaceuticals, cosmetics and other consumer goods at its FDA registered, cGMP and ISO 17025 compliant testing facility.
Sparta, NJ, February 16th, 2021
A Texas company recently announced the voluntary recall of one lot of topical gel used for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor skin irritations. The over-the-counter (OTC) product was distributed nationwide to wholesalers and healthcare facilities.
According to the company announcement posted by the U.S. Food & Drug Administration (FDA), the recall occurred after two customers complained of visible contamination. The product was then tested and found to be contaminated with the bacteria Burkholderia cepacia (B. cepacia). The notice goes on to state that topical application of the product contaminated with B. cepacia may result in local skin infections. For immunocompromised patients, including patients receiving chemotherapy and patients with cystic fibrosis, the skin infection is more likely to spread into the blood stream leading to life-threatening sepsis which include symptoms such as fever, difficulty breathing, low blood pressure, fast heart rate, mental confusion and possibly death.
Burkholderia cepacia is the name for a group or “complex” 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. B cepacia can be resistant to common antibiotics making potentially contaminated products used in healthcare environments particularly concerning.
MPL Laboratories’ testing experts operate an FDA and DEA registered facility that offers cGMP and ISO 17025 compliant microbiology testing of OTC medicines and personal care products, pharmaceuticals, cosmetics and other consumer goods. These testing services are available to manufacturers, importers, distributors, regulatory agencies and healthcare providers.
To learn more about microbial 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 ISO/IEC 17025 accredited by PJLA, FDA and DEA registered, 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.