Drug product
Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 NDC 0904-6979-40
D-0289-2022
Product summary
- Event
- Event 88811
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,239 bottles
- Official record key
drug-enforcement:D-0289-2022
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot, expiry: Lot H00005, exp 01/2022; Lot H00006, exp 04/2022; Lot H00007, exp 07/2022
Distribution pattern: Nationwide USA
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications