Hand Sanitizer Recalled Due to Microbial Contamination Concerns
MPL Laboratories provides sterility and microbial testing services for personal care products, pharmaceuticals, over-the-counter (OTC) medicines, cosmetics, and other consumer goods at its FDA registered, cGMP, ISO 17025 compliant testing facility.
Sparta, NJ, June 7th, 2021
A company based in Florida recently announced the voluntary recall of 26 lots of antimicrobial hand sanitizers manufactured from February through June of last year. The product was packaged in multiple sizes and distributed to select retailers nationwide. The recall is due to microbial contamination concerns caused by Burkholderia cepacia complex and Ralstonia pickettii.
According to the company announcement, posted by the U.S. Food & Drug Administration (FDA): Use of a hand sanitizer contaminated with Burkholderia cepacia complex and Ralstonia pickettii can range from no reaction to serious infections in a person with a hand-wound or scrapes. The bacteria could enter the bloodstream, especially in patients with compromised immune systems. Health care professionals who use this contaminated hand sanitizer and tend to an at-risk patient, such as one with cystic fibrosis, could lead to adverse events ranging from a localized infection to lung or bloodstream infections, which could require patient hospitalization.
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 agency states that it typically poses little medical risk to healthy people, but those with certain health issues may be more susceptible to infections. B. cepacia can be resistant to common antibiotics making potentially contaminated products used in medical environments particularly concerning. Ralstonia pickettii is a Gram-negative bacterium, and it's found in soil and other moist environments. This bacterium is increasingly viewed as an emerging nosocomial pathogen, especially for immunocompromised patients.
MPL Laboratories operates an FDA and DEA registered facility that offers cGMP and ISO 17025 compliant microbiology testing of pharmaceuticals, OTC medicines, cosmetics, personal care products, food, and other consumer goods.
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 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.