Stop using nowDrug recall · FDA · Published January 26, 2022
AuroMedics Polymyxin B Injection Recall: Hair Found in Vials
AuroMedics Pharma recalls Polymyxin B for Injection due to hair discovered in vials. This sterile prescription drug (NDC 55150-234-10) may contain particulate matter. Affected lots: CPB200013 (exp 9/2022).
“AuroMedics Polymyxin B Injection Recall: Hair Found in Vials.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35253-auromedics-polymyxin-b-injection-recall-hair-found-in-vials. Based on FDA recall #D-0556-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0556-2022%22&limit=1).
AuroMedics Pharma LLC voluntarily recalled Polymyxin B for Injection USP due to the presence of particulate matter, including a hair found in a vial, according to the FDA. The Food and Drug Administration announced the Class I recall on January 26, 2022.
How to tell if you have it
Brand: AuroMedics
Product: Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials per carton
NDC: 55150-234-10
Lot code: CPB200013
Expiration date: 9/2022
Units affected: 35,520 vials
The hazard
The recall addresses the presence of particulate matter in the sterile injection product. The FDA cited a specific product complaint where hair was discovered in a vial within the affected lot.
Context
GovInfoNow's records show AuroMedics Pharma LLC has issued 22 other recalls since December 4, 2017. Recent similar recalls include an Acyclovir Injection recall on September 26, 2022, for particulate matter and a Tranexamic Acid Injection recall on the same date for metal particulates. Other recent recalls of similar products include a Fondaparinux Injection recall (September 30, 2022) for subpotent drug risk, an American Regent Multrys IV injection recall (July 24, 2026) for particulate matter contamination, and a Fresenius Kabi Glycopyrrolate Injection recall (July 16, 2026) for hair found in the product.
How to tell if you have this one
Check for vials labeled 'Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL' with lot number CPB200013 (expiring 9/2022). The product is sterile and prescription-only.
Brand
AuroMedics
Category
Drug
Based on the official FDA remedy
What to do — step by step
Stop Using Now
Immediately stop using the recalled Polymyxin B for Injection vials with lot number CPB200013.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide in the US” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.6 years after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0556-2022 (January 26, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0556-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.