Sparta, NJ, July 31, 2025
Last month, the U.S. Food & Drug Administration (FDA) posted information about the recall of three lots of a prescription antibiotic in tablet form. The manufacturer recalled the tablets because they may exhibit black spots on the surface due to microbial contamination.
According to the recall risk statement:
Oral products contaminated with Aspergillus may result in serious and life-threatening infections. The use of the defective product in patients with underlying immunosuppressive conditions increases the concern for serious infections.
It was shared that the observance of the black spots on the tablets was reported in a product quality complaint. The impacted lots were distributed to wholesalers and distributors nationwide between December 4, 2024, and May 5, 2025. Fortunately, at the time of the recall posting, the manufacturer had not received any reports of adverse events, illnesses, or injuries.
Dedicated to helping prevent these types of costly product recalls that can put patients and consumers at risk are the scientists at MPL Laboratories. Their product testing experts identify contamination and sterility issues in a state-of-the-art facility that is FDA registered and DEA licensed. MPL Laboratories proudly offers cGMP and ISO 17025 compliant sterility and microbiology testing of pharmaceuticals, over-the-counter (OTC) medicines, cosmetics, personal care products, and other consumer goods. These services are available to manufacturers, importers, distributors, regulatory agencies, healthcare providers, and the public.
To learn more about microbial, sterility, or other 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. MPL’s staff includes a Ph.D. Diplomat of the American Board of Toxicology, M.S. and B.S. degreed microbiologists, along with other dedicated scientific personnel. The microbiology testing laboratory serves the pharmaceutical, cosmetic, and personal care product industries. MPL strives to provide its clients with reliable, defensible test data delivered in a timely manner. The laboratory is part of the EMSL Analytical network of laboratories across the United States and Canada.
