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Recall Observatory FDA recall evidence

Drug product

allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-count cartons (NDC 11673-617-22), b)30-count cartons (NDC 11673-617-39), c)70-count cartons (NDC 11673-617-01), and d)150-count cartons (11673-617-47), Distributed by: Target Corporation, Minneapolis, MN 55403.

D-0910-2023

February 09, 2023

Class II

Product summary

Firm
L. Perrigo Company
Event
Event 91672
Status
Terminated
Classification
Class II
Quantity
208,416 cartons
Official record key
drug-enforcement:D-0910-2023

Official wording

Reason: Failed Impurities/Degradation Specifications

Code information: Lot #: a) 2HE2032, 2JE1882, 2JE2185 Exp. Date 01/24; b) 2DR0464, 2ER0410, Exp. Date 12/23; 2ER0286, 2ER0411, Exp. Date 01/24 c) 2DR0467, 2DR0468, 2DR0469, 2ER0288, Exp. Date 12/23 d) 2ER0414, Exp. Date 01/24, 2GR0333, Exp. Date 02/24

Distribution pattern: Nationwide within the USA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Impurities/Degradation Specifications