D-1867-2019 Class II Terminated
FDA drug recall D-1867-2019 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: 71,748 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
- 71,748 bottles
Product Description
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
Distribution Pattern
Nationwide in the USA
Code Information
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1867-2019
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026