D-1869-2019 Class II Terminated

Recalled by Aurolife Pharma, LLC — Dayton, NJ

FDA drug recall D-1869-2019 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: 129,600 cartons.

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
129,600 cartons

Product Description

Allergy Relief (Fexofenadine HCl) tablets USP, 180 mg, 15-count cartons, equate, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-995-62.

Reason for Recall

Failed Impurities/Degradation Specifications

Distribution Pattern

Nationwide in the USA

Code Information

Lot #s: 067180010A, Exp 03/21; 067180023C1, 067180024D1, Exp 07/21