Drug product
Rite Aid ALLERGY RELIEF Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 24 count bottle, Made in the Czech Republic, Distributed by Rite Aid 30 Hunter Lane Camp Hill PA 17011 NDC 11822-0425-0 UPC 0 11822 85410 8
D-0347-2022
Product summary
- Event
- Event 88384
- Status
- Terminated
- Classification
- Class II
- Quantity
- 79,776 containers
- Official record key
drug-enforcement:D-0347-2022
Official wording
Reason: Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Code information: Lot # 0JE2487, EXP 01/31/2022; 0ME2515, Exp 04/30/2022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out of specification