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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 79481-0847-0), b)30-count cartons (NDC 79481-0847-1), and c) 45-count cartons (NDC 79481-0847-2), Distributed by: MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544.

D-0906-2023

February 09, 2023

Class II

Product summary

Firm
L. Perrigo Company
Event
Event 91672
Status
Terminated
Classification
Class II
Quantity
59,688 cartons
Official record key
drug-enforcement:D-0906-2023

Official wording

Reason: Failed Impurities/Degradation Specifications

Code information: Lot #: a) 2JE1882, Exp. date 01/24 b) 2FV1918, 2ER0411, Exp. date 01/24; 2GV1902, Exp. date 04/24; 2CR0652, 2DR0465, Exp. date 12/23; 2GR0329, Exp. date 04/24 c)2CR0653, 2DR0466, Exp. date 12/23; 2ER0287, 2ER0412, Exp. date 01/24

Distribution pattern: Nationwide within the USA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Impurities/Degradation Specifications