Clofarabine Injection (Sanofi-Aventis) – Incorrect Packaging (2017)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Clofarabine injection, 20 mg/20 mL, 20 mL Single-Use Vial, Rx only, Mfd by: Teva Pharmachemle, Swensweg 5, Haarlem, The Netherlands; Mfd for: Winthrop U.S., a business of sanofi-aventis U.S. LLC, Bridgewater, NJ 08807; NDC 0955-1746-01.
Brand
Sanofi-Aventis U.S. LLC
Lot Codes / Batch Numbers
Lot #: K5006Y02, Exp 31AUG18
Products Sold
Lot #: K5006Y02, Exp 31AUG18
Sanofi-Aventis U.S. LLC is recalling Clofarabine injection, 20 mg/20 mL, 20 mL Single-Use Vial, Rx only, Mfd by: Teva Pharmachemle, Swens due to Labeling: Incorrect or Missing Package Insert: authorized generic product was packaged with the incorrect insert for the brand name product Clolar (cl. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Labeling: Incorrect or Missing Package Insert: authorized generic product was packaged with the incorrect insert for the brand name product Clolar (clofarabine) injection.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026