Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials per carton, Sterile, Rx Only, Distributed by: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-234-10

Recall Insight

This FDA Drug action (record #D-0556-2022) was formally reported on February 16, 2022, with the manufacturer initiating the action on January 26, 2022. It is classified under Critical severity (Class I), with a current status of Terminated. AuroMedics Pharma LLC is listed as the recalling firm, operating out of East Windsor, NJ. Federal records indicate 35,520 vials units are affected.

The documented reason for this recall is: Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot Distribution data in the federal record shows the product reached: Nationwide in the US. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 5 were also issued by FDA Drug. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 4 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.