D-1865-2019 Class II Terminated
FDA drug recall D-1865-2019 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: a) 9662 cartons; b) 7382 cartons; c) 5184 cartons; d) 9842 cartons.
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
- a) 9662 cartons; b) 7382 cartons; c) 5184 cartons; d) 9842 cartons
Product Description
Allergy Relief (Fexofenadine Hydrochrloride) Tablets USP, 180 mg, packaged in a) 15-count cartons (NDC 60000-409-53); b) 30-count cartons (NDC 60000-409-30); c) 45-count bonus cartons (NDC 60000-409-48); d) 45-count cartons (NDC 60000-409-45); CAREone, Distributed by: Foodhold U.S.A., LLC, Landover, MD 20785.
Reason for Recall
Failed Impurities/Degradation Specifications
Distribution Pattern
Nationwide in the USA
Code Information
Lot #s: a) 067180025D1, Exp 07/21; b) 067180025B1, Exp 07/21; c) 067180025A1, Exp 07/21; d) 067180025C1, Exp 07/21
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1865-2019
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026