Class II · Moderate risk
Med Pride
CGMP Deviations; deficiencies observed during FDA inspection
Polymyxin B for Injection USP
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
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
Affected NDC
55150-0234-10
Compare with the code on your package — it is the most precise check available.
Drug: Polymyxin
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Polymyxin B NDC 55150-0234 |
SULFATE 500000 [USP'U]/1 | Injection, Powder, Lyophilized, for Solution Intramuscular|intrathecal|intravenous|ophthalmic |
Eugia US LLC | Rx |
- Recalling firm
- AuroMedics Pharma LLC
- NDC code
- 55150-234-10
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- Company announcement
- Jan 26, 2022 · FDA notice with lot numbers
- FDA recall number
- D-0556-2022 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Polymyxin recalls
See all
Class II · Moderate risk
Rapidol
CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk
Lil Drug Store
CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk
Circle K
CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk
Lucky Super Soft
CGMP Deviations; deficiencies observed during FDA inspection
Other recalls by AuroMedics Pharma LLC
All 2022 recalls
Class II · Moderate risk
Fondaparinux Sodium Injection
Subpotent Drug: Out of specification for assay
Class III · Low risk
Tranexamic Acid Injection
Presence of Particulate Matter: Piece of metal found in a vial
Class II · Moderate risk
Acyclovir Sodium Injection
Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
Class II · Moderate risk
Acetaminophen Injection 1
Discoloration and failed pH specifications
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.