FDA Drug recall D-928-2013
CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618 NDC 0703-3249-11
- FDA Drug
- Class II
- terminated
- Published 2013-09-11
On 2013-09-11 the FDA classified a Class II recall of CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618 NDC 0703-3249-11 by Teva Pharmaceuticals Usa, citing lack of Assurance of Sterility: The required reduction of endotoxin was not met during the annual revalidation of the vial washer.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-928-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-08-13 |
| Published | 2013-09-11 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | US |
Product
CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618 NDC 0703-3249-11
Reason
Lack of Assurance of Sterility: The required reduction of endotoxin was not met during the annual revalidation of the vial washer.
Identifiers
| code_info | Lot 31314458B, 31314459B exp.08/14, 31315794 exp. 10/14, 31315982B exp.11/14 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-928-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.