FDA recall D-0353-2026

McKesson · Class I · drug

Product

UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only, Manufactured by Accord BioPharma, Inc., 8041 Arco Corporate Drive, Suite 200, Raleigh, NC 27617, NDC 69448-025-63

Reason for recall

Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment instead of the required refrigerated environment.

Distribution

Nationwide in the USA

Key facts

Status
Ongoing
Initiation date
2026-01-16
Report date
2026-02-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Irving, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0353-2026