Clolar — Class III drug recall D-0075-2018
Terminated recall by Genzyme Corporation, reported 2017-11-22, distributed nationwide. Labeling: Incorrect or Missing Package Insert.
| Recall number | D-0075-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Genzyme Corporation, Northborough, MA, United States |
| Recall initiated | 2017-10-12 |
| Classified | 2017-11-10 |
| Reported by FDA | 2017-11-22 |
| Terminated | 2020-09-10 |
| Distributed | Nationwide (US) |
| Quantity | 9,343 single |
| Reason classes | labeling |
| NDC | 00024-5860-01 |
| Lot numbers | K5006Y01, K5006Y03, K6001Y01 |
| Expiration dates | 2018-08-31, 2019-03-31 |
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.
Reason for recall
Labeling: Incorrect or Missing Package Insert.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0075-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.