IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single dose vial, Manufactured by Accord BioPhar
Summary
The FDA issued a Class II for IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single d by ACCORD BIOPHARMA INC. Reason: Lack of assurance of Sterility:.
Details
Source
Drug Recall
External ID
D-0653-2026
Action Date
2026-07-08
Status
Ongoing
Category
drug
Product Description
IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single dose vial, Manufactured by Accord BioPharma Inc., 8041 Arco corporate Drive, Suite 200, Raleigh, NC 27617, USA, Manufactured at: Catalent Indiana, LLC, 1300 S. Patterson Drive, Bloomington, IN 47403, USA, NDC 69448-019-26.
Lot/Code Info: Lot # 004L24A, Exp Date: 02/19/2027.
Quantity Affected: 326 vials
Reason for Recall
Lack of assurance of Sterility:
Distribution
US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-10
Company
Raleigh, NC
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 39 drug recalls issued in the same week, part of 81 drug-related FDA actions this month.
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 (ACCORD BIOPHARMA INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ACCORD BIOPHARMA INC have FDA actions?
This is the only FDA action we have on record for ACCORD BIOPHARMA INC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0653-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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