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.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: K5006Y02, Exp 31AUG18
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0056-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 13, 2017
- FDA report date
- Nov 8, 2017
- Quantity
- 422 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sanofi-Aventis U.S. LLC
Original FDA data
Every field from FDA enforcement report D-0056-2018, exactly as published.
Show all FDA fields
- City
- Bridgewater
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 78232
- Address
- 55 Corporate Dr
- Code information
- Lot #: K5006Y02, Exp 31AUG18
- Postal code
- 08807-1265
- Report date
- Nov 8, 2017
- Product type
- Drugs
- Recall number
- D-0056-2018
- Classification
- Class III
- Recalling firm
- Sanofi-Aventis U.S. LLC
- Product quantity
- 422 vials
- Termination date
- May 13, 2020
- Reason for recall
- Labeling: Incorrect or Missing Package Insert: authorized generic product was packaged with the incorrect insert for the brand name product Clolar (clofarabine) injection.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Oct 13, 2017
- Initial firm notification
- Letter
- Center classification date
- Oct 30, 2017