Reported Nov 8, 2017 · Terminated
Clofarabine injection, 20 mg/20 mL, 20 mL Single-Use Vial, Rx only, Mfd by
Sanofi-Aventis U.S. LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sanofi-Aventis U.S. LLC · 55 Corporate Dr · Bridgewater, NJ · 08807-1265
Is this the product you have?
Clofarabine injection, 20 mg/20 mL, 20 mL Single-Use Vial, Rx only, Mfd by
3 of 3 products
| # | Product as published |
|---|---|
| 1 | Teva Pharmachemle, Swensweg 5, Haarlem, The Netherlands |
| 2 | Mfd for: Winthrop U.S., a business of sanofi-aventis U.S. LLC, Bridgewater, NJ 08807 |
| 3 | NDC 0955-1746-01. |
- Lot codes and dates
Lot #: K5006Y02Exp 31AUG18
- Amount recalled
- 422 vials
Where it was sold
- Nationwide
Why it was recalled
Labeling: Incorrect or Missing Package Insert: authorized generic product was packaged with the incorrect insert for the brand name product Clolar (clofarabine) injection.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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