AuroMedics Pharma Recalls Certain Polymyxin B For Injection

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AuroMedics Pharma LLC is recalling certain Polymyxin B for Injection USP, 500,000 Units/Vial to the consumer level in the United States citing the possible presence of particulate matter, the U.S. Food and Drug Administration said.

Polymyxin B for Injection USP is a sterile, white lyophilized cake or powder, suitable for preparation of sterile solutions for intramuscular, intravenous, intrathecal, or ophthalmic use indicated in the treatment of infections or the urinary tract, meninges, and bloodstream caused by susceptible strains of bacteria.

The recall includes lot number CPB200013 of Polymyxin B for Injection with an expiration date of 09/2022. The product is packaged in a carton containing vials for Parenteral or Ophthalmic Administration, NDC 55150-234-10.

AuroMedics shipped the entire lot to wholesalers nationwide from March 19, 2021, through June 14, 2021.

The East Windsor, New Jersey -based company initiated the recall following a product complaint for the presence of particulate matter, identified as hair being discovered in a vial within this lot.

According to the agency, the administration of an intravenous product containing hair, even with the use of a filter, could cause a patient to experience serious hypersensitivity reactions that may be life- threatening.

However, the company has not received reports of any adverse events or identifiable safety concerns related to the affected product to date.

Consumers/distributors/retailers are asked to immediately stop using the product and return them to place of purchase/contact their doctor as appropriate.

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