HIGH

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...

Lack of Assurance of Sterility

Quick Facts at a Glance

Recall Date
May 8, 2026
Hazard Level
HIGH
Brands
CIMZIA, UCB, Inc.
Geographic Scope
1 states

Hazard Information

Lack of Assurance of Sterility

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact UCB Biosciences Inc. or your healthcare provider for guidance. Notification method: Letter

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Full Description

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.. Generic: CERTOLIZUMAB PEGOL; Brand: CIMZIA. Reason: Lack of Assurance of Sterility. Classification: Class II. Quantity: 141,708 cartons. Distribution: US Nationwide.

Safety Guide

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Product Classification

Product Details

Model Numbers
Lot: CVZFW
Exp.:2026-JUL-04
CVZYG
Exp.: 2026-AUG-19
CWSYT
+15 more
UPC Codes
50474-700
50474-710
50474-750
+6 more
Affected States
ALL
Report Date
May 27, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE