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D-0573-2020 Class II Terminated

Recalled by AuroMedics Pharma LLC — East Windsor, NJ

FDA drug recall D-0573-2020 was initiated by AuroMedics Pharma LLC on Nov 11, 2019 and is designated Class II. Reason for recall: Presence of Foreign Substance: Foreign material found inside the vial. The recall status is terminated (terminated Nov 17, 2020). Affected quantity: 111,850 vials.

Recall Details

Product Type: Drugs
Report Date: Dec 4, 2019
Initiation Date: Nov 11, 2019
Termination Date: Nov 17, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 111,850 vials

Product Description

Lidocaine HCl Injection, USP, 2% 100 mg/5 mL (20 mg/mL), Preservative-Free, packaged in 10 x 5 mL Single Dose Vials per carton, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-165-05.

Reason for Recall

Presence of Foreign Substance: Foreign material found inside the vial.

Distribution Pattern

Nationwide in the USA

Code Information

Batch #: CLC190049, Exp 02/2022

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0573-2020
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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