Clolar (clofarabine) 20 mg/20 mL (1 mg/mL) Injection, for intravenous use, Rx Only, Mfd. by: Tev...
FDA Recall #D-0075-2018 — Class III — October 12, 2017
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.
Recalling Firm
Genzyme Corporation — Northborough, MA
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
9,343 single dose vials
Distribution
Nationwide
Code Information
Lot #: K5006Y01; Exp. 08/31/18 Lot #: K5006Y03; Exp. 08/31/18 Lot #: K6001Y01; Exp. 03/31/19
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated