CLASS III Drug recall · Reported 8 Nov 2017 · FDA Enforcement Report
Clofarabine injection, 20 mg/ Single-Use Vial recalled
Sanofi-Aventis U.S is recalling Clofarabine injection, 20 mg/ Single-Use Vial, distributed nationwide in the US. The recall was initiated on 13 Oct 2017 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0056-2018
- FDA event ID
- 78232
- Recalling firm
- Sanofi-Aventis U.S, Bridgewater, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 13 Oct 2017
- FDA classified
- 30 Oct 2017
- Reported
- 8 Nov 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Injectable & IV Drugs
Timeline
| 13 Oct 2017 | Recall initiated by company | |
| 30 Oct 2017 | Classified by FDA | +17 days |
| 8 Nov 2017 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it 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 lots are affected?
Lot #: K5006Y02, Exp 31AUG18
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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