Recalls / Class III
Class IIID-0056-2018
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.
- Affected lot / code info
- Lot #: K5006Y02, Exp 31AUG18
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.
Recalling firm
- Firm
- Sanofi-Aventis U.S. LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 55 Corporate Dr, N/A, Bridgewater, New Jersey 08807-1265
Distribution
- Quantity
- 422 vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2017-10-13
- FDA classified
- 2017-10-30
- Posted by FDA
- 2017-11-08
- Terminated
- 2020-05-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0056-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.