| Category |
Press Release |
| Publish Date |
4/21/2020 |
| Author |
Paul Cochrane |
| Title |
Injectable Drug Manufacturer Recalls Products Due to a Lack of Assurance of Sterility |
| Introduction |
MPL Laboratories provides sterility and other pharmaceutical testing services in its FDA registered, cGMP and ISO 17025 compliant testing facility. |
Sparta, NJ, April 21 st, 2020
The U.S. Food & Drug Administration (FDA) recently posted information about a pharmaceutical company that operates as an outsourcing facility that has voluntarily recalled various injectable drug products. According to the recall notice, the action was taken “due to a lack of assurance of sterility.”
The injectable pharmaceuticals were distributed nationwide, but fortunately at the time of the recall notice, the company had not received any reports of adverse events and is recalling these sterile products out of an abundance of caution to promote patient safety. Customers with any of the recalled products are advised to not use them.
The administration of any injectable drug that is supposed to be sterile, but is not, could result in serious infections if microbial pathogens are present. The safety of the nation’s prescription drug supply is a critical issue for drug manufacturers, healthcare providers and patients. Anytime contaminated prescription or over-the-counter (OTC) drugs reach consumers, the situation could result in illnesses and deaths, expensive lawsuits, damaged public relations and even plant closures in extreme cases.
Working to help prevent these types of situations from occurring are the scientists at MPL Laboratories. Their FDA and DEA registered facility offers cGMP compliant sterility and microbiology testing of pharmaceuticals, OTC medicines, cosmetics and personal care products. MPL’s scientists have decades of experience testing these types of products. They are able to rapidly identify issues in raw ingredients, the manufacturing process, and in final products that could cause sterility or other product quality issues. These and other testing services are available to pharmaceutical companies, importers, distributors, retailers, regulatory agencies and healthcare providers in the United States, Canada and across the globe.
To learn more about this or other pharmaceutical, over-the-counter (OTC) medicine, cosmetic or personal care product testing services offered 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.
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