FDA DrugsClass II
IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single d...
Published: July 8, 2026Recall ID: D-0653-2026Category: drugsCountry: US
Reason for Recall / Hazard
Lack of assurance of Sterility:
Product Description & Identification
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Raleigh |
| State | NC |
| Openfda › Upc › 1 | 0369448017637 |
| Openfda › Upc › 2 | 0369448018634 |
| Openfda › Unii | FU77B4U5Z0 |
| Openfda › Route | SUBCUTANEOUS |
| Openfda › Rxcui › 1 | 2717067 |
| Openfda › Rxcui › 2 | 2717074 |
| Openfda › Rxcui › 3 | 2717078 |
| Openfda › Rxcui › 4 | 2717083 |
| Openfda › Rxcui › 5 | 2717085 |
| Openfda › Rxcui › 6 | 2717086 |
| Openfda › Spl id | be75347b-ab5d-4104-b90e-7c7b1f46fbef |
| Openfda › Brand name | IMULDOSA |
| Openfda › Spl set id | 2539a6cf-0fe5-1565-e063-6294a90a3618 |
| Openfda › Package ndc › 1 | 69448-018-63 |
| Openfda › Package ndc › 2 | 69448-017-63 |
| Openfda › Package ndc › 3 | 69448-019-26 |
| Openfda › Product ndc › 1 | 69448-017 |
| Openfda › Product ndc › 2 | 69448-018 |
| Openfda › Product ndc › 3 | 69448-019 |
| Openfda › Generic name | USTEKINUMAB-SRLF |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | USTEKINUMAB-SRLF |
| Openfda › Manufacturer name | Accord BioPharma Inc. |
| Openfda › Application number | BLA761364 |
| Openfda › Is original packager | true |
| Event id | 99216 |
| Address 1 | 8041 Arco Corporate Dr Ste 200 |
| Address 2 | N/A |
| Code info | Lot # 004L24A, Exp Date: 02/19/2027. |
| Postal code | 27617-2091 |
| Report date | 20260708 |
| Product type | Drugs |
| Product quantity | 326 vials |
| Reason for recall | Lack of assurance of Sterility: |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260610 |
| Initial firm notification | Letter |
| Center classification date | 20260629 |
Overview
- Recalling FirmACCORD BIOPHARMA INC
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide.