Drug product
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.
D-0075-2018
Product summary
- Event
- Event 78286
- Status
- Terminated
- Classification
- Class III
- Quantity
- 9,343 single dose vials
- Official record key
drug-enforcement:D-0075-2018
Official wording
Reason: Labeling: Incorrect or Missing Package Insert.
Code information: Lot #: K5006Y01; Exp. 08/31/18 Lot #: K5006Y03; Exp. 08/31/18 Lot #: K6001Y01; Exp. 03/31/19
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing