IMAAVY Injection Recalled for Presence of Particulate Matter
J&J Innovative Medicine is recalling 49 vials of IMAAVY (nipocalimab-aahu) injection due to the presence of particulate matter. The affected lot was distributed in Ohio.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as Class II due to the presence of particulate matter in the IMAAVY injection. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
J&J Innovative Medicine is recalling 49 vials of IMAAVY (nipocalimab-aahu) Injection, 300 mg/1.62 mL, for intravenous infusion. The recall is due to the presence of particulate matter in the product.
The affected product is identified by Lot JNYJ1208 with an expiration date of 10/30/2027. The NDC is 57894-800-01. The recall is classified as Class II by the FDA.
The source text does not specify the distribution scope beyond the state of Ohio. Consumers and healthcare providers should stop using the affected vials and contact their healthcare provider or the manufacturer for further instructions.
The recalled product
- Product
- IMAAVY (NIPOCALIMAB-AAHU)
- Brand
- IMAAVY
- Manufacturer
- J&J INNOVATIVE MEDICINE
- Category
- Drug — Prescription Injection
- Hazard
- Affected units
- 49
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 JNYJ1208
- Exp. 10/30/2027
Distribution
Distributed in 1 state:
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