IMAAVY (nipocalimab-aahu) Injection, 300 mg /1.62 mL (185 mg/mL) per single-dose vial, For Intravenous Infusion After Dilution, Rx only, Ma…
J&J INNOVATIVE MEDICINE · Presence of particulate matter.
- Status
- Ongoing
- City
- Malvern
- State
- PA
- Country
- United States
- Classification
- Class II
- Product type
- Drugs
- Event ID
- 99972
- Recalling firm
- J&J INNOVATIVE MEDICINE
- Address 1
- 200 Great Valley Pkwy
- Address 2
- N/A
- Postal code
- 19355-1307
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- Letter
- Distribution pattern
- OH
- Recall number
- D-0016-2027
- Product quantity
- 49 vials
- Reason for recall
- Presence of particulate matter.
- Recall initiation date
- 20260923
- Center classification date
- 20261008
- Report date
- 20261014
- Code info
- Lot JNYJ1208; Exp. 10/30/2027
- 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
- Harmonized identifiers (openFDA)
- Application number
- BLA761430
- Brand name
- IMAAVY
- Generic name
- NIPOCALIMAB-AAHU
- Manufacturer name
- Janssen Biotech, Inc.
- Product NDC
- 57894-800, 57894-801
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- INTRAVENOUS
- Substance name
- NIPOCALIMAB
- RxCUI
- 2712699, 2712706, 2712708, 2712709
- SPL ID
- 38376edc-230b-4b2b-8bb6-55b9dccea7a5
- SPL set ID
- 8886274c-f2b2-48af-85c1-2f90bfe304b8
- Package NDC
- 57894-801-01, 57894-800-01
- Is original packager
- true
- UNII
- 87M90CV8NC