Recalls / Class III
Class IIID-0075-2018
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.
- Affected lot / code info
- Lot #: K5006Y01; Exp. 08/31/18 Lot #: K5006Y03; Exp. 08/31/18 Lot #: K6001Y01; Exp. 03/31/19
Why it was recalled
Labeling: Incorrect or Missing Package Insert.
Recalling firm
- Firm
- Genzyme Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 11 Forbes Rd, N/A, Northborough, Massachusetts 01532-2501
Distribution
- Quantity
- 9,343 single dose vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-10-12
- FDA classified
- 2017-11-10
- Posted by FDA
- 2017-11-22
- Terminated
- 2020-09-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0075-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.