D-0075-2018 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 22, 2017
- Initiation Date
- October 12, 2017
- Termination Date
- September 10, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9,343 single dose vials
Product Description
Clolar (clofarabine) 20 mg/20 mL (1 mg/mL) Injection, for intravenous use, Rx Only, Mfd. by: Teva Pharmachemie Swensweg 5 Haarlem, The Netherlands Mfd. for: Genzyme Corporation, Cambridge, MA 02142, NDC 0024-5860-01.
Reason for Recall
Labeling: Incorrect or Missing Package Insert.
Distribution Pattern
Nationwide
Code Information
Lot #: K5006Y01; Exp. 08/31/18 Lot #: K5006Y03; Exp. 08/31/18 Lot #: K6001Y01; Exp. 03/31/19