D-1864-2019 Class II Terminated
FDA drug recall D-1864-2019 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: 8,240 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
- 8,240 bottles
Product Description
Fexofenadine Hydrochrloride Tablets USP, 180 mg, 100-count bottle, Distributed by: Aurohealth LLC., 2572 Brunswick Pike, Lawrenceville, NJ 08648, NDC 58602-711-21
Reason for Recall
Failed Impurities/Degradation Specifications
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: 067180008A, Exp 03/21