FDA MedWatch - Polymyxin B for Injection USP, Vial by AuroMedics Pharma:

Recall - Due to the Presence of Particulate Matter

If your email program has trouble displaying this email, view as a webpage. MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Polymyxin B for Injection USP, 500,000 Units per Vial by AuroMedics Pharma: Recall - Due to the Presence of Particulate Matter AUDIENCE: Patient, Health Professional, Pharmacy ISSUE: AuroMedics Pharma is recalling lot number CPB200013 of Polymyxin B for Injection USP, 500,000 Units per Vial due to a product complaint for the presence of particulate matter, identified as hair being discovered in a vial within this lot. Risk Statement: 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. To date, AuroMedics Pharma has not received reports of any adverse events or identifiable safety concerns attributed to the product consumed from this lot. For more information about this recall, click on the red button "Read Recall" below. BACKGROUND: 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. RECOMMENDATIONS:  AuroMedics Pharma LLC is notifying its distributors by recall letters and is arranging for return/replacement of all recalled product. Consumers/distributors/retailers that have the product lot which is being recalled should immediately stop using and return to place of purchase/contact their doctor as appropriate. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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