Sparta, NJ, September 1, 2022
In June, the U.S. Food & Drug Administration (FDA) posted information about the recall of a nasal allergy swab for children due to microbial contamination concerns. The homeopathic product is used by swabbing the nose and is meant to relieve allergy symptoms.
One lot of the product, with an August 2024 expiration date, is part of the voluntary recall. The product was sold nationwide to wholesale distributors, retail stores and online. The recall was initiated after FDA testing found some product to contain elevated levels of yeast and mold, and it may contain a type of bacteria known as Bacillus cereus.
According to the published recall risk statement:
In immunocompromised patients, the use of the affected product could potentially result in severe or life-threatening adverse events such as bacteremia/sepsis, pneumonia, invasive fungal rhinosinusitis, or disseminated fungal infection. In non-immunocompromised patients, the population most likely to use the product, the use of the defective product may result in infectious complications, for instance bacteremia or noninvasive fungal rhinosinusitis, but in this population the infections are expected to be less severe and more readily responsive to treatment.
Working to help manufacturers and importers of over-the-counter (OTC) medicines and pharmaceuticals prevent these types of costly product recalls, and the health risks associated with contaminated products reaching consumers, are the microbial experts at MPL Laboratories. Their scientists provide microbial testing for a broad spectrum of contaminants, including yeasts, fungi and bacteria. All testing takes place in MPL’s FDA registered and cGMP, ISO 17025 compliant laboratory to help ensure the highest quality results.
To learn more about microbial testing for OTC medicines, pharmaceuticals, personal care products, cosmetics or other goods, 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.