Drug product
Fexofenadine HCl Tablets, 180 mg, Pkg Size 90, Mfg: Aurohealth LLC, Repackaged by Preferred Pharmaceuticals, Inc., Anaheim, CA, NDC #: 68788-6848-09
D-1877-2019
Product summary
- Event
- Event 83711
- Status
- Terminated
- Classification
- Class II
- Quantity
- 79 (90 ct.) bottles
- Official record key
drug-enforcement:D-1877-2019
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot #: G0219K, Exp 3/2021; C1419E, Exp 3/2021
Distribution pattern: Product was distributed to 1 physician in Gainesville Florida.
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications