Spectrum Laboratory Products has voluntarily recalled all batches of epinephrine USP, a bulk API powder utilized in the production of the pharmaceutical product. The recall was issued to customers around the world. The FDA has received numerous reports of “discolored” products as the primary complaint.
The company’s recall notice was published Monday by the FDA. The product recall includes all shipments of bulk active pharmaceutical ingredients to the U.S. and Canada. Namely, lots 1KG0865, 2KL0353, and 2KF0151 were found to be defective.
Asthma, hypersensitivity reactions, heart problems, high blood pressure, and shock are just a few of the many life-threatening illnesses that epinephrine is used to treat.
The FDA warns that manufacturing the final product with discolored material could reduce the effectiveness of the product and maybe even cause death.
Spectrum’s compliance manager, Tej Parikh, remarked that while discoloration from exposure to oxygen is possible, it is not always indicative of a loss of efficacy.
“In this situation, discoloration was limited to three lots of our Epinephrine (L-Adrenaline) USP product line. As a matter of precaution, Spectrum Laboratory Products has proactively decided to voluntarily recall these three lots. No other lots of our Epinephrine USP product line are affected and we have not received any reports of adverse events related to this recall,” Parikh stated.
The company claims no incidents related to the recall have been reported as of yet. Common uses for epinephrine include relieving symptoms of anaphylaxis and other life-threatening allergic responses caused by insect bites, stings, medications, foods, and other allergens. It’s also effective against asthma-related anaphylaxis, as well as bronchospasm, airway edema, and other similar conditions.
The FDA also stated that Spectrum is informing distributors and customers and making preparations for the return of recalled merchandise. Anyone using a product with the catalog number EP130, including customers, pharmacists, and wholesalers, should stop doing so immediately. Anyone experiencing adverse effects while using this medication should speak with their doctor immediately.
Spectrum Labs, headquartered in San Francisco, provides AI-powered data analysis services. To gain insights and identify customer growth prospects, The company uses a natural language processing and data categorization approach to evaluate raw text data in real-time.
At the start of last year, the tech-based firm raised $32 million in Series B funding. It announced back then that the money would be used to expand the reach of the company’s AI-powered content moderation infrastructure for online communities by creating tools for use by the HR, sales, customer support, and brand safety departments of businesses.
Spectrum Labs currently collaborates with over 20 businesses across the dating, gaming, marketplace, and social network industries. These firms include Grindr, The Meet Group, and Minerva. The company is also planning to move into the enterprise services sphere soon, as it feels its expertise will be well suited in that domain.
It remains to be seen exactly what ramifications the company will face as a result of the product recall, but customer trust will definitely take a hit.