Drug product
TopCare Allergy Relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, packaged as a) 5 count bottle, NDC 36800-319-13 UPC 0 36800 33277-5 b) 15 count bottle, NDC 36800-319-22 UPC 0 36800 33278 2; c) 45 count bottle, NDC 36800-319-95 UPC 0 36800 33280-5; d) 90 count bottle, NDC 36800-319-75 UPC 0 36800 33282 9; Distributed Topco Associates LC, Elk Grove Village, IL 60007, Made in the Czech Republic,
D-0350-2022
Product summary
- Event
- Event 88384
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13,656 containers
- Official record key
drug-enforcement:D-0350-2022
Official wording
Reason: Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Code information: Lot # a) 0KE2429, Exp 02/28/2022; b) 0HE2530, Exp 12/31/2021; c)0FR0460, Exp 02/28/2022; d)0GR0531, Exp 03/31/2022 ; 0KR0465, Exp 04/302022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out of specification