AuroMedics Pharma LLC 2022-02-16 Health critical FDA
Health · FDA · Recall #FDA-D-0556-2022
Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials… Recall
Issued February 16, 2022 · AuroMedics Pharma LLC
In February 2022, AuroMedics Pharma LLC recalled the Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
What you should do
- 1 Stop using Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact AuroMedics Pharma LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- AuroMedics Pharma LLC
- Category
- Health
- Recall date
- February 16, 2022
- Units affected
- Not reported
- Sold at
- Nationwide in the US
- Recall number
- FDA-D-0556-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- AuroMedics Pharma LLC has 3 recalls in our database, including 1 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.