Drug product
Fexofenadine Hydrochrloride Tablets USP, 180 mg, 100-count bottle, Distributed by: Aurohealth LLC., 2572 Brunswick Pike, Lawrenceville, NJ 08648, NDC 58602-711-21
D-1864-2019
Product summary
- Event
- Event 83581
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8,240 bottles
- Official record key
drug-enforcement:D-1864-2019
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot #: 067180008A, Exp 03/21
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications