Huntington Beach, CA, March 14th, 2022
The U.S. Food & Drug Administration (FDA) recently posted information about a manufacturer of FDA-registered products in California that announced a voluntary recall of one lot of a wound care gel. The recall was initiated because of concerns over potential microbial contamination with Bacillus cereus. The gel was distributed to 61 physician clinics in 17 states.
According to the recall notice:
Patients who apply the contaminated product to a wound could develop a skin and soft tissue infection which could lead to serious complications. For non-immunocompromised patients these infections are expected to be less severe and responsive to treatment. However, for the immunocompromised patients and preterm neonates, Bacillus cereus can cause life-threatening, invasive infections including wound and blood infections, sepsis, pneumonia, and meningitis.
“Fortunately, at the time of the recall posting, the manufacturer had not had any reports of adverse events related to the product,” said Michael Chapman, Laboratory Manager at LA Testing’s Huntington Beach facility. “At LA Testing, we are dedicated to helping manufacturers, distributors, retailers, and importers avoid these types of costly product recalls, and the health risks associated with contaminated products reaching consumers. With multiple laboratories in California, LA Testing provides microbial and chemical testing for a broad spectrum of contaminants, including Bacillus cereus. We also provide services such as shelf life testing, contamination source tracking, and sterility and sanitation validation.”
To learn more about product testing services, please visit www.LATesting.com, email info@LATesting.com or call (800) 755-1794.
About LA Testing
LA Testing is California’s leading laboratory for indoor air quality testing of asbestos, mold, lead, VOCs, formaldehyde, soot, char, ash, and smoke damage, particulates, and other chemicals. In addition, LA Testing offers a full range of air sampling and investigative equipment to professionals and the public. LA Testing maintains an extensive list of accreditations including: AIHA-LAP, LLC (AIHA-LAP, LLC EMLAP, AIHA-LAP, LLC IHLAP, AIHA-LAP, LLC ELLAP), CDC ELITE, NVLAP, State of California, State of Hawaii Department of Health, and other states. LA Testing, along with the EMSL Analytical, Inc. network, has multiple laboratories throughout California including South Pasadena, Huntington Beach, San Leandro, San Diego, and Ontario.