Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials per carton, Sterile, Rx Only, D
Summary
The FDA issued a Class I for Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in by AuroMedics Pharma LLC. Reason: Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot.
Details
Source
Drug Recall
External ID
D-0556-2022
Action Date
2022-02-16
Status
Terminated
Category
drug
Product Description
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
Lot/Code Info: Lot CPB200013, exp 9/2022
Quantity Affected: 35,520 vials
Reason for Recall
Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
Distribution
Nationwide in the US
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-26
Company
East Windsor, NJ
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 104 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
AuroMedics Pharma LLC has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (AuroMedics Pharma LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does AuroMedics Pharma LLC have FDA actions?
AuroMedics Pharma LLC has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0556-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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