Drug Enforcement D-0907-2023

Failed Impurities/Degradation Specifications

Status

Terminated

Classification

Class II

Report Date

July 19, 2023

Termination Date

September 11, 2023

Product Information

Product description
Fexofenadine Hydrochloride Tablets, 180 mg, 100-count cartons, Distributed by: Perrigo, Allegan, MI 49010. NDC 45802-847-78
Product quantity
15,504 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-0907-2023
Event ID
91672
Recall initiation date
February 9, 2023
Center classification date
July 11, 2023
Code info
Lot #: 2DR0351, Exp. date 12/23
More code info