Skip to content
Recall Observatory FDA recall evidence

Drug product

basic+care, allergy Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24 HR, 150 count bottle, Made in the Czech Republic, Distributed by: Perrigo Allergan, MI 49010, NDC 0113-7571-47 UPC 3 70030 11470 2

D-0331-2022

July 27, 2021

Class II

Product summary

Firm
Perrigo Company PLC
Event
Event 88384
Status
Terminated
Classification
Class II
Quantity
28,320 containers
Official record key
drug-enforcement:D-0331-2022

Official wording

Reason: Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.

Code information: Lot # 0GR0528, Exp 03/31/22; 0KR0473, Exp 04/30/22; 0LR0369, Exp 06/30/22

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out of specification