IMULDOSA injection recalled due to lack of sterility assurance
Accord BioPharma is recalling IMULDOSA (ustekinumab-srlf) Injection due to lack of assurance of sterility. The affected lot was distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class II recall. A sterility defect in an injectable drug for systemic use poses risk of serious infection and potential hospitalization; lack of sterility assurance in a prescription injection product meets the Severe criteria.
Plain-English summary
Accord BioPharma Inc. is recalling IMULDOSA (ustekinumab-srlf) Injection, 130 mg/26 mL, a prescription medication administered by subcutaneous injection. The recall affects lot #004L24A with an expiration date of 02/19/2027, which comprises 326 vials distributed nationwide.
The recall is due to lack of assurance of sterility. Patients who have received this product should contact their healthcare provider. Healthcare providers should not dispense units from the recalled lot and should return any affected vials to Accord BioPharma Inc.
The recalled product
- Product
- IMULDOSA (USTEKINUMAB-SRLF)
- Brand
- IMULDOSA
- Manufacturer
- ACCORD BIOPHARMA INC
- Category
- Drug — Injectable / Prescription
- Affected units
- 326
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 004L24A
- Exp Date: 02/19/2027.
UPCs (2)
- 0369448017637
- 0369448018634
Distribution
Distributed nationwide across the United States.
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