Home / Recalls / Aurolife Pharma, LLC / D-1871-2019

D-1871-2019 Class II Terminated

Recalled by Aurolife Pharma, LLC — Dayton, NJ

FDA drug recall D-1871-2019 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: 6104 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: 6104 bottles

Product Description

Fexofenadine HCL Tablets USP, 180 mg, 500's BRITE STOCK; Manufactured for: Aurohealth LLC., 2572 Brunswick Pike, Lawrenceville, NJ 08648; Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810.

Reason for Recall

Failed Impurities/Degradation Specifications

Distribution Pattern

Nationwide in the USA

Code Information

Lot #s:067180011A, 067180012A, Exp 04/21, 06718027B1, Exp 09/21

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1871-2019
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.

Other recalls by Aurolife Pharma, LLC

D-0877-2023 Class III — Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by… (May 18, 2023)
D-0087-2023 Class II — Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by… (Dec 16, 2022)
D-0736-2022 Class II — Glycopyrrolate Tablets, USP, 1 mg, 100-count bottle, Rx Only, Distributed by… (Mar 17, 2022)
D-1874-2019 Class II — Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count cartons… (Aug 23, 2019)
D-1873-2019 Class II — Wal-Fex (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 5-count cartons… (Aug 23, 2019)
D-1866-2019 Class II — Allergy Relief (fexofenadine hydrochrloride) tablets, 180 mg, 5-count carton… (Aug 23, 2019)
D-1865-2019 Class II — Allergy Relief (Fexofenadine Hydrochrloride) Tablets USP, 180 mg, packaged in a)… (Aug 23, 2019)
D-1864-2019 Class II — Fexofenadine Hydrochrloride Tablets USP, 180 mg, 100-count bottle, Distributed… (Aug 23, 2019)
D-1867-2019 Class II — fexofenadine hydrochloride tablets USP, 180 mg, 150-count bottle, Member's Mark… (Aug 23, 2019)
D-1872-2019 Class II — Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count bottles… (Aug 23, 2019)