D-1872-2019 Class II Terminated

Recalled by Aurolife Pharma, LLC — Dayton, NJ

FDA drug recall D-1872-2019 was initiated by Aurolife Pharma, LLC on August 23, 2019 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications The recall status is terminated (terminated August 16, 2022). Affected quantity: 240 bottles.

Recall Details

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

Product Description

Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count bottles, Distributed by: Aurohealth LLC, 2572 Brunswick Pike, Lawrenceville, NJ 08648; NDC 58602-820-09.

Reason for Recall

Failed Impurities/Degradation Specifications

Distribution Pattern

Nationwide in the USA

Code Information

Lot #: 067180026A1, Exp 07/21