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Pharmaceutical Company Recalls Prescription Ointment Due to Microbial Contamination Concerns

By: WebWire

In late December, the U.S. Food & Drug Administration (FDA) posted information about the voluntary recall of a lot of a prescription ointment produced by a pharmaceutical company based in New York. The recall was initiated due to the presence of Ralstonia pickettii bacteria.

According to the recall notice:

R. pickettii is present in the natural environment (soil, water) and for healthy individuals with intact skin, is unlikely to cause any localized or systemic infections. However, for individuals who are immunocompromised, or whose skin is not intact (i.e. sunburn, psoriasis, abrasions), there is a reasonable possibility that systemic infections may occur if the product is contaminated with R. pickettii due to the presence of the corticosteroid component which enhances absorption of the ointment. If this bacterium is circulating in the human blood stream it can cause life-threatening, invasive infections such as sepsis, pneumonia, meningitis, inflammation of the bone or bone marrow, and infection in the joint fluid and joint tissues.

Fortunately, at the time of the notice, the manufacturer had not received any adverse event reports related to the recalled lot. The ointments were distributed to two wholesale distributors in the U.S. who may have further distributed this lot to their retail customers for prescription dispensing to patients who were prescribed the drug.

The safety of the nation's prescription drug supply is a critical issue for pharmaceutical companies, distributors, healthcare providers and patients everywhere. Whenever contaminated prescriptions or over-the-counter (OTC) drugs reach patients, the situation could result in illnesses and deaths, costly litigation and fines, and damaged public relations. This is why the scientists at MPL Laboratories offer their expertise to help avert these types of scenarios. Their FDA and DEA registered facility offers cGMP and ISO 17025 compliant microbial of pharmaceuticals, OTC medicines, cosmetics, and personal care products.

To learn more about product testing services offered by MPL Laboratories, please visit, call (800) 548-1874 or email .

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.

— WebWireID287444 —

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