Drug Enforcement D-0912-2023

Failed Impurities/Degradation Specifications

Status

Terminated

Classification

Class II

Report Date

July 19, 2023

Termination Date

September 11, 2023

Product Information

Product description
Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 36800-691-39), b)45-count cartons (NDC 36800-691-95), and 90-count cartons (NDC 36800-691-75), Distributed by: Topco Associates LLC, Elk Grove Village, IL 60007.
Product quantity
44,280 cartons
Reason for recall
Failed Impurities/Degradation Specifications
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide within the USA

Location & Firm

Recalling firm
L. Perrigo Company
Address
515 Eastern Ave, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0912-2023
Event ID
91672
Recall initiation date
February 9, 2023
Center classification date
July 11, 2023
Code info
Lot #: a) 2FV1948, 2ER0285, 2ER0411, Exp. Date 01/24 b)2CR0653, Exp. Date 12/23 c)2GR0331, Exp. Date 04/24
More code info
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