AuroMedics Pharma is voluntarily recalling 1 lot of Polymyxin B for Injection USP, 500,000 Unit per vial to the consumer level due to the presence of particulate matter, which was identified as hair discovered in a vial.
Polymyxin B for Injection is indicated for the treatment of susceptible infections due to Pseudomonas aeruginosa including urinary tract infections (UTIs), meninges, bloodstream, and eye infections. It is also indicated for the treatment of other serious susceptible infections including H. influenza meningeal, E. coli UTIs, and bacteremia due to A. aerogenes and K. pneumoniae.
The recalled lot of Polymyxin B for Injection USP, 500,000 Unit/Vial; NDC 55150-234-10; Lot Number CPB200013; Expiration Date 09/2022, was distributed to wholesalers nationwide between March 19, 2021 to June 14, 2021.
Administration of intravenous product containing hair could potentially lead to serious, life-threatening hypersensitivity reactions. To date, the Company has not received reports of any adverse events or identifiable safety concerns.
Adverse reactions or quality problems should be reported to the Food and Drug Administration’s MedWatch program.
For more information regarding this recall contact AuroMedics Pharma LLC at (866) 850-2876 Option 2 or by email at [email protected].
AuroMedics Pharma LLC issues voluntary nationwide recall of Polymyxin B for Injection USP, 500,000 Unit per vial, due to the presence of particulate matter. News release. AuroMedics Pharma LLC. January 26, 2022. Accessed January 31, 2022. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/auromedics-pharma-llc-issues-voluntary-nationwide-recall-polymyxin-b-injection-usp-500000-unit-vial