Drug product
Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count bottles, Distributed by: Aurohealth LLC, 2572 Brunswick Pike, Lawrenceville, NJ 08648; NDC 58602-820-09.
D-1872-2019
Product summary
- Event
- Event 83581
- Status
- Terminated
- Classification
- Class II
- Quantity
- 240 bottles
- Official record key
drug-enforcement:D-1872-2019
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot #: 067180026A1, Exp 07/21
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications