Home / Recalls / Aurolife Pharma, LLC / D-1864-2019

D-1864-2019 Class II Terminated

Recalled by Aurolife Pharma, LLC — Dayton, NJ

FDA drug recall D-1864-2019 was initiated by Aurolife Pharma, LLC on Aug 23, 2019 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications The recall status is terminated (terminated Aug 16, 2022). Affected quantity: 8,240 bottles.

Recall Details

Product Type: Drugs
Report Date: Sep 25, 2019
Initiation Date: Aug 23, 2019
Termination Date: Aug 16, 2022
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 8,240 bottles

Product Description

Fexofenadine Hydrochrloride Tablets USP, 180 mg, 100-count bottle, Distributed by: Aurohealth LLC., 2572 Brunswick Pike, Lawrenceville, NJ 08648, NDC 58602-711-21

Reason for Recall

Failed Impurities/Degradation Specifications

Distribution Pattern

Nationwide in the USA

Code Information

Lot #: 067180008A, Exp 03/21

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1864-2019
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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