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D-0574-2020 Class II Terminated

Recalled by AuroMedics Pharma LLC — East Windsor, NJ

FDA drug recall D-0574-2020 was initiated by AuroMedics Pharma LLC on Nov 25, 2019 and is designated Class II. Reason for recall: Discoloration: Product complaints of discoloration after reconstitution of vials. The recall status is terminated (terminated Mar 4, 2021). Affected quantity: 275,060 vials.

Recall Details

Product Type: Drugs
Report Date: Dec 18, 2019
Initiation Date: Nov 25, 2019
Termination Date: Mar 4, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 275,060 vials

Product Description

Vancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-count vials per carton, Rx only, Mft. in India for: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-204-20.

Reason for Recall

Discoloration: Product complaints of discoloration after reconstitution of vials.

Distribution Pattern

Nationwide in the USA

Code Information

Lot #: CVM180003, CVM180004, Exp 04/2020; CVM180008, Exp 07/2020; CVM180009, CVM180010, CVM180011, CVM180012, Exp 09/2020

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0574-2020
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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