Drug Enforcement D-0573-2025

CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.

Status

Ongoing

Classification

Class II

Report Date

August 13, 2025

Termination Date

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Product Information

Product description
RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01
Product quantity
3 units
Reason for recall
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide Within the U.S.

Location & Firm

Recalling firm
Cardinal Health Inc.
Address
7000 Cardinal Pl, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0573-2025
Event ID
97360
Recall initiation date
July 30, 2025
Center classification date
August 7, 2025
Code info
Lot: TRB23802AC, Expires: 03/18/2026; TRA22804AA, Expires: 10/18/2025
More code info
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