Drug Enforcement D-0911-2023

Failed Impurities/Degradation Specifications

Status

Terminated

Classification

Class II

Report Date

July 19, 2023

Termination Date

September 11, 2023

Product Information

Product description
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
Product quantity
6,216 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-0911-2023
Event ID
91672
Recall initiation date
February 9, 2023
Center classification date
July 11, 2023
Code info
Lot#: 2DR0471, Exp. Date 12/23
More code info
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