FDA recall D-0714-2026

McKesson · Class II · drug

Product

Gemcitabine Injection, 1 g per 26.3 mL (38 mg/mL), 26.3 mL Single-Dose Vial, For Intravenous Infusion ONLY, Rx only, Manufactured by: THYMOORGAN PHARMAZIE GmbH, Schiffgraben 23, 38690 Goslar, Germany; Distributed by: Hikma, Berkeley Heights, NJ 07922. NDC: 0143-9341-01

Reason for recall

Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.

Distribution

Nationwide within the United States

Key facts

Status
Ongoing
Initiation date
2026-06-10
Report date
2026-07-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Irving, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0714-2026