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Recall Observatory FDA recall evidence

Drug product

Picnic, Fexofenadine Hydrochloride Tablets, 180 mg, Antihistamine, 90-count cartons, Distributed by: Thirty Madison, Inc., New York, NY 10001. NDC 45 tablets: 80159-112-03

D-0911-2023

February 09, 2023

Class II

Product summary

Firm
L. Perrigo Company
Event
Event 91672
Status
Terminated
Classification
Class II
Quantity
6,216 cartons
Official record key
drug-enforcement:D-0911-2023

Official wording

Reason: Failed Impurities/Degradation Specifications

Code information: Lot#: 2DR0471, Exp. Date 12/23

Distribution pattern: Nationwide within the USA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Impurities/Degradation Specifications