Drug product
H.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg/Antihistamine packaged as a) 15 count bottle, NDC 37808-571-22, UPC 0 41220 53081 6; b) 30 count bottle, NDC 37808-571-39, UPC 0 41220 53082 3; c) 45 count bottle, NDC 37808-571-95, UPC 0 41220 53083 0; Made with Pride & Care for H.E.B. San Antonio TX 78204, Product of Czech Republic,
D-0340-2022
Product summary
- Event
- Event 88384
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13,920 containers
- Official record key
drug-enforcement:D-0340-2022
Official wording
Reason: Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Code information: Lot a) 0HE2530, Exp 12/31/2021; 0JE2407, Exp 2/28/2022: b) 1BR0462, Exp 10/31/2022 c) 0FR0460, Exp 2/28/2022: 0LR0363, Exp 6/30/2022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out of specification