D-0016-2027 Class II Ongoing
FDA drug recall D-0016-2027 was initiated by J&J INNOVATIVE MEDICINE on Sep 23, 2026 and is designated Class II. Reason for recall: Presence of particulate matter. The recall status is ongoing. Affected quantity: 49 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 14, 2026
- Initiation Date
- Sep 23, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 49 vials
Product Description
IMAAVY (nipocalimab-aahu) Injection, 300 mg /1.62 mL (185 mg/mL) per single-dose vial, For Intravenous Infusion After Dilution, Rx only, Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044. NDC: 57894-800-01
Reason for Recall
Presence of particulate matter.
Distribution Pattern
OH
Code Information
Lot JNYJ1208; Exp. 10/30/2027
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0016-2027
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026