FDA DrugsClass II
cimzia (certolizumab pegol), 2x200mg/mL PREFILLED SYRINGES (2 single-dose), Rx O...
Published: May 27, 2026Recall ID: D-0546-2026Category: drugsCountry: US
Reason for Recall / Hazard
Lack of Assurance of Sterility
Product Description & Identification
cimzia (certolizumab pegol), 2x200mg/mL PREFILLED SYRINGES (2 single-dose), Rx ONLY, Manufactured by: UCB Inc., Smyrna, GA 30080, a) NDC 50474-710-79, b) Professional sample, NDC 50474-710-80; c) 3 cartons, STARTER KIT, NDC 50474-710-81.
Additional Source Details
| Field | Value |
|---|---|
| City | Smyrna |
| State | GA |
| Openfda › Nui › 1 | N0000175610 |
| Openfda › Nui › 2 | N0000175451 |
| Openfda › Unii | UMD07X179E |
| Openfda › Rxcui › 1 | 795081 |
| Openfda › Rxcui › 2 | 795085 |
| Openfda › Rxcui › 3 | 849597 |
| Openfda › Rxcui › 4 | 849599 |
| Openfda › Rxcui › 5 | 2724369 |
| Openfda › Rxcui › 6 | 2724370 |
| Openfda › Rxcui › 7 | 2724371 |
| Openfda › Rxcui › 8 | 2724372 |
| Openfda › Spl id | 4b984e6f-72ac-4fdc-e063-6394a90af105 |
| Openfda › Brand name | CIMZIA |
| Openfda › Spl set id | b4c2c9dc-a0bb-4d64-a667-a67ebe88392d |
| Openfda › Package ndc › 1 | 50474-700-62 |
| Openfda › Package ndc › 2 | 50474-700-61 |
| Openfda › Package ndc › 3 | 50474-710-79 |
| Openfda › Package ndc › 4 | 50474-710-80 |
| Openfda › Package ndc › 5 | 50474-710-81 |
| Openfda › Package ndc › 6 | 50474-750-10 |
| Openfda › Product ndc › 1 | 50474-700 |
| Openfda › Product ndc › 2 | 50474-710 |
| Openfda › Product ndc › 3 | 50474-750 |
| Openfda › Generic name | CERTOLIZUMAB PEGOL |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Pharm class epc | Tumor Necrosis Factor Blocker [EPC] |
| Openfda › Pharm class moa | Tumor Necrosis Factor Receptor Blocking Activity [MoA] |
| Openfda › Manufacturer name | UCB, Inc. |
| Openfda › Application number | BLA125160 |
| Openfda › Is original packager | true |
| Event id | 98915 |
| Address 1 | 1950 Lake Park Dr SE |
| Code info | Lot: CVZFW, Exp.:2026-JUL-04; CVZYG, Exp.: 2026-AUG-19; CWSYT, Exp.: 2026-OCT-22; CWDZY, Exp.:2026-NOV-20; CWTSD, Exp.:2026-DEC-11; CVTFK, Exp.:2026-JUL-04; CVTSN, Exp.: 2026-AUG-19; CWVGP. Exp.:2026-DEC-11; CVWXT, CVWXV, CVWXW, Exp.:2026-JUL-04; CWHFF, Exp.: 2026-OCT-22; CWNDS, Exp.: 2026-DEC-11. |
| Postal code | 30080-7648 |
| Report date | 20260527 |
| Product type | Drugs |
| Product quantity | 141,708 cartons |
| Reason for recall | Lack of Assurance of Sterility |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260508 |
| Initial firm notification | Letter |
| Center classification date | 20260520 |
Overview
- Recalling FirmUCB Biosciences Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide.