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.
Reported: November 8, 2017 Initiated: October 13, 2017 #D-0056-2018
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.
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.
Details
- Recalling Firm
- Sanofi-Aventis U.S. LLC
- Units Affected
- 422 vials
- Distribution
- Nationwide in the USA
- Location
- Bridgewater, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Sanofi-Aventis U.S. LLC. Units affected: 422 vials.
Why was this product recalled? ▼
Labeling: Incorrect or Missing Package Insert: authorized generic product was packaged with the incorrect insert for the brand name product Clolar (clofarabine) injection.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 8, 2017. Severity: Low. Recall number: D-0056-2018.
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