Drug recall D-1867-2019

Class II Terminated reported Sep 25, 2019

Product

fexofenadine hydrochloride tablets USP, 180 mg, 150-count bottle, Member's Mark, Distributed by: Sam's West, Inc., Bentonville, AR 22716, NDC 68196-976-91, UPC 0 78742 23550 9.

Reason for recall

Failed Impurities/Degradation Specifications

Lots and codes

Lot #'s: 067180009A, Exp 03/21; 067180013A, 067180014A, 067180015A, Exp 04/21; 067180018A, Exp 05/21; 067180020A, Exp 06/21; 067180021A1, 067180022A1, Exp 07/21; 06718028A1, 06718028B1, Exp 09/21; 06719001A3, Exp 01/22

Recall details

Recalling firm
Aurolife Pharma, LLC, Dayton, NJ
Quantity
71,748 bottles
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
August 23, 2019
Terminated
August 16, 2022