Drug product
Fexofenadine HCL Tablets USP, 180 mg, 500's BRITE STOCK; Manufactured for: Aurohealth LLC., 2572 Brunswick Pike, Lawrenceville, NJ 08648; Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810.
D-1871-2019
Product summary
- Event
- Event 83581
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6104 bottles
- Official record key
drug-enforcement:D-1871-2019
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot #s:067180011A, 067180012A, Exp 04/21, 06718027B1, Exp 09/21
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications