Sanofi Recalls Clofarabine Injection Vials Due to Incorrect Package Insert
Sanofi-Aventis is recalling 422 vials of Clofarabine injection because the authorized generic product was packaged with the incorrect package insert for the brand name product.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a packaging/labeling error involving the package insert, which falls under the 'Low' severity criteria for documentation issues.
Plain-English summary
Sanofi-Aventis U.S. LLC is recalling 422 vials of Clofarabine injection, 20 mg/20 mL, 20 mL Single-Use Vial. The product is an authorized generic manufactured by Teva Pharmachemle in The Netherlands for Winthrop U.S., a business of sanofi-aventis U.S. LLC. The specific lot number is K5006Y02, with an expiration date of August 31, 2018. The NDC number is 0955-1746-01.
The recall was initiated because the authorized generic product was packaged with the incorrect package insert intended for the brand name product, Clolar (clofarabine) injection. This labeling error resulted in the distribution of the product with inaccurate documentation.
The affected product was distributed nationwide in the USA. Healthcare providers and patients who have this specific lot of Clofarabine injection should contact their healthcare provider or the recalling firm for further instructions on how to handle the product.
The recalled product
- 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.
- Manufacturer
- Sanofi-Aventis U.S. LLC
- Category
- Drug — Injection
- Hazard
- Affected units
- 422
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: K5006Y02
- Exp 31AUG18
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Sanofi-Aventis U.S. LLC
See all →- HighADMELOG Insulin Lispro Recalled for Malformed Seal Defect
FDA (Drugs) · 2023-05-24
- ModerateSanofi Recalls Elitek (Rasburicase) Vials Due to Stability Testing Failures
FDA (Drugs) · 2020-08-26
- SevereSanofi Recalls Zantac Tablets Due to NDMA Impurity
FDA (Drugs) · 2019-12-11
- SevereSanofi Recalls Regular Strength Zantac 75 mg Due to NDMA Impurity
FDA (Drugs) · 2019-12-11
- SevereSanofi Recalls Zantac 150 mg Tablets Due to NDMA Impurity
FDA (Drugs) · 2019-12-11
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- LowGenzyme Recalls Clolar Injection Due to Missing Package Insert
FDA (Drugs) · 2017-11-22
- LowEnoxaparin Sodium Injection Recalled for Labeling Error on Declared Strength
FDA (Drugs) · 2018-01-17
- ModerateSanofi Recalls Eloxatin Injection Due to Manufacturing Practice Deviations
FDA (Drugs) · 2012-07-11
- SevereSanofi Recalls Over-Concentrated Docetaxel Injection Vials Nationwide
FDA (Drugs) · 2018-05-09
- LowSanofi Recalls Mozobil Vials Due to Incorrect or Missing Package Insert
FDA (Drugs) · 2017-05-17
- ModerateSanofi-aventis Recalls Eloxatin Injection Due to Manufacturing Issues
FDA (Drugs) · 2012-07-11