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D-0556-2022 Class I Terminated

Recalled by AuroMedics Pharma LLC — East Windsor, NJ

FDA drug recall D-0556-2022 was initiated by AuroMedics Pharma LLC on Jan 26, 2022 and is designated Class I. Reason for recall: Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot The recall status is terminated (terminated Aug 20, 2024). Affected quantity: 35,520 vials.

Recall Details

Product Type: Drugs
Report Date: Feb 16, 2022
Initiation Date: Jan 26, 2022
Termination Date: Aug 20, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 35,520 vials

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

Reason for Recall

Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot

Distribution Pattern

Nationwide in the US

Code Information

Lot CPB200013, exp 9/2022

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0556-2022
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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