Sparta, NJ, January 9
th, 2020
A pharmaceutical compounding company recently announced a recall of over 30 lots of a topical anesthetic that was packaged with other medical items. According to the announcement, the product has been found to potentially contain microbial contamination in the non-sterile base component of the convenience packs that were distributed nationwide to hospitals, pharmacies and other distributors.
The U.S. Food & Drug Administration (FDA) also posted the voluntary recall late last year that impacts specific products lots that have expiration dates ranging from November of 2019 to February of 2021. The published information states that FDA analysis identified
Bacillus fortis/Geobacillus toebii,
Bacillus species and
Bacillus circulans as contaminants in some samples obtained during an inspection of the company. The recall notice also warns:
This non-sterile product has the potential to result in an increased chance of infection at the site of administration during open wound care. The use of this or other non-sterile products in wound treatment may increase the risk of infection, especially for immunocompromised patients, the elderly or children.
Bacillus species are widely distributed throughout the environment. Its spores are resistant to disinfectants, sterilization, radiation, desiccation and efforts to destroy them through high or low temperatures. This makes them a significant contamination challenge for manufacturers of medical supplies, consumer products and even food products.
Dedicated to helping manufacturers and public health officials identify
Bacillus species and other microbial contaminants are the scientists at MPL Laboratories. MPL operates an FDA registered and DEA licensed facility that offers cGMP and ISO 17025 compliant microbiology testing of medical supplies, pharmaceuticals, personal care products, cosmetics, foods, beverages and other goods. These services are available to manufacturers, importers, distributors, regulatory agencies and healthcare providers.
To learn more about this or other sterility and microbiological 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 a PhD Diplomat of the American Board of Toxicology, M.S. and B.S. degreed microbiologists, and other dedicated scientists. The microbiology testing laboratory serves the pharmaceutical, medical device, 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 network of over 40 laboratories across the United States and Canada.
