Drug Enforcement D-0314-2024

CGMP Deviations

Status

Completed

Classification

Class II

Report Date

February 14, 2024

Termination Date

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Product Information

Product description
Febuxostat Tablets, 40 mg, 30 Tablets (3 x 10) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-538-21, NDC Unit dose 60687-538-11
Product quantity
1,932 cartons
Reason for recall
CGMP Deviations
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
USA Nationwide

Location & Firm

Recalling firm
Amerisource Health Services LLC
Address
2550 John Glenn Ave Ste A

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

Codes & Dates

Recall number
D-0314-2024
Event ID
93918
Recall initiation date
January 25, 2024
Center classification date
February 6, 2024
Code info
Lot # 1015033, exp. 06/30/2025; 1016409, exp. 08/31/2025
More code info
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