Drug Safety Alerts

AuroMedics Polymyxin B for Injection Consumer-Level Recall

1/26/2022

On January 26, 2022, AuroMedics Pharma LLC issued a consumer-level recall of one lot of Polymyxin B for Injection USP, 500,000 Units/Vial NDC #55150-0234-10. This recall was issued due to a product complaint for the presence of particulate matter, identified as hair being discovered in a vial within the affected lot.

This could be a health hazard or safety risk to patients using product affected by this recall.

This recall affects lot CPB200013 exp. 09/2022. No other lots are affected by this recall. AuroMedics shipped the entire lot to wholesalers nationwide from March 19, 2021, through June 14, 2021.

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. According to AuroMedics Pharma LLC, as of the date of recall, it has not received reports of any adverse events or identifiable safety concerns attributed to the product consumed from this lot.

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 (membranes that protect the brain and spinal cord), and bloodstream caused by susceptible strains of bacteria. It is packaged in a carton containing vials for Parenteral or Ophthalmic Administration.

CVS Caremark Response:

Please note: This product is not carried by the CVS Caremark Mail Order Pharmacies.

For more information about this recall, please call AuroMedics Pharma LLC at 1-866-850-2876 option 2, Monday through Friday, 8:00 am to 5:00 pm (ET) or email at pvg@aurobindousa.com.

You may also call the United States Food and Drug Administration (FDA) at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit www.fda.gov.