Drug product
Health Mart, Fexofenadine Hydrochloride tablets, 24HR, 180mg . Antihistamine 70 count bottle, Distributed by: Mckesson 6555 State Highway 161, Irvine, TX 75039. Made in the Czech Republic, NDC 62011-0233-1, UPC 0 52569 13787 1
D-0338-2022
Product summary
- Event
- Event 88384
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,960 containers
- Official record key
drug-enforcement:D-0338-2022
Official wording
Reason: Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Code information: Lot 0FR0461, Exp 2/25/2022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out of specification