D-0714-2026 Class II Ongoing
FDA drug recall D-0714-2026 was initiated by McKesson on June 10, 2026 and is designated Class II. Reason for recall: Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment. The recall status is ongoing. Affected quantity: 74 units.
Recall Details
- Product Type
- Drugs
- Report Date
- July 8, 2026
- Initiation Date
- June 10, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 74 units
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
Reason for Recall
Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: CB0046, Exp. Date 06/2027