ACCORD BIOPHARMA INC: IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single dose vial, Manufactured by Accord BioPharma Inc., 8041 Arco c
Read the official notice at FDA (drug) →
The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- ACCORD BIOPHARMA INC
- Product
- 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.
- Reason / hazard
- Lack of assurance of Sterility:
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide.
- Recall initiated
- 2026-06-10
- Code info
- Lot # 004L24A, Exp Date: 02/19/2027.
- Product quantity
- 326 vials
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Raleigh
- State
- NC
- Country
- United States
- Event id
- 99216
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