Clofarabine injection recall: Labeling Error
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…
Why was Clofarabine injection recalled?
Labeling: Incorrect or Missing Package Insert: authorized generic product was packaged with the incorrect insert for the brand name product Clolar (clofarabine) injection.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: K5006Y02, Exp 31AUG18
- 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…
- Recalling firm
- Sanofi-Aventis U.S. LLC
- Quantity
- 422 vials
- Distribution
- Nationwide in the USA
- Recall date
- November 8, 2017
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)