RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142
Summary
The FDA issued a Class II for RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda by Cardinal Health Inc.. Reason: CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements..
Details
Source
Drug Recall
External ID
D-0573-2025
Action Date
2025-08-13
Status
Ongoing
Category
drug
Product Description
RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01
Lot/Code Info: Lot: TRB23802AC, Expires: 03/18/2026; TRA22804AA, Expires: 10/18/2025
Quantity Affected: 3 units
Reason for Recall
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Distribution
Nationwide Within the U.S.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-07-30
Company
Dublin, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 55 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Cardinal Health Inc. has 14 FDA actions in our database, including 14 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Cardinal Health Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cardinal Health Inc. have FDA actions?
Cardinal Health Inc. has 14 FDA actions in our database, including 14 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0573-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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