CLASS I Drug recall · Reported 16 Feb 2022 · FDA Enforcement Report
Polymyxin B for Injection USP per Vial vials recalled
AuroMedics Pharma is recalling Polymyxin B for Injection USP per Vial vials, distributed nationwide in the US. The recall was initiated on 26 Jan 2022 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0556-2022
- FDA event ID
- 89457
- Recalling firm
- AuroMedics Pharma, East Windsor, NJ
- Brand
- Polymyxin B
- Manufacturer
- Eugia US LLC
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 26 Jan 2022
- FDA classified
- 10 Feb 2022
- Reported
- 16 Feb 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 26 Jan 2022 | Recall initiated by company | |
| 10 Feb 2022 | Classified by FDA | +15 days |
| 16 Feb 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
Product as listed by the FDA
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
Where it was distributed
Nationwide in the US
Questions about this recall
Why was it recalled?
Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
Which lots are affected?
Lot CPB200013, exp 9/2022
Where was it sold?
Nationwide in the US
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from AuroMedics Pharma
All 36| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Fondaparinux Sodium Injection, USP, 7.5 mg per, Single Dose recalledFondaparinux Sodium | AuroMedics Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Acyclovir Sodium Injection, 500mg/ (50mg/mL) Single Dose Vial recalledAcyclovir Sodium | AuroMedics Pharma | Particulate Matter | Nationwide |
| Drug | CLASS III | Tranexamic Acid Injection, USP, 1000mg recalled by AuroMedics PharmaTranexamic Acid | AuroMedics Pharma | Particulate Matter | Nationwide |
| Drug | CLASS II | Acetaminophen Injection 1,000 mg recalled by AuroMedics PharmaAcetaminophen | AuroMedics Pharma | Other | Nationwide |
| Drug | CLASS III | Glycopyrrolate Injection, USP 4 mg recalled by AuroMedics PharmaGlycopyrrolate | AuroMedics Pharma | Potency & Assay | LA, MS, OH |
Other Polymyxin B recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution recalled | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |