Gemcitabine Injection, 1 g per 26.3 mL (38 mg/mL), 26.3 mL Single-Dose Vial, For Intravenous Infusion ONLY, Rx only, Man
Summary
The FDA issued a Class II for Gemcitabine Injection, 1 g per 26.3 mL (38 mg/mL), 26.3 mL Single-Dose Vial, For by McKesson. Reason: Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment..
Details
Source
Drug Recall
External ID
D-0714-2026
Action Date
2026-07-08
Status
Ongoing
Category
drug
Product Description
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
Lot/Code Info: Lot #: CB0046, Exp. Date 06/2027
Quantity Affected: 74 units
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
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-10
Company
Irving, TX
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 49 drug recalls issued in the same week, part of 77 drug-related FDA actions this month.
McKesson has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (McKesson) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does McKesson have FDA actions?
McKesson has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0714-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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