FDA Drug recall D-154-2013
Carboplatin Injection, 450 mg/45 mL (10 mg/mL), 45 mL, Cytotoxic Agent, Sterile, Multi-Dose Vial, Rx only, For IV Use, NDC 61703-339-50 (Ho…
- FDA Drug
- Class I
- completed
- Published 2013-02-13
On 2013-02-13 the FDA classified a Class I recall of Carboplatin Injection, 450 mg/45 mL (10 mg/mL), 45 mL, Cytotoxic Agent, Sterile, Multi-Dose Vial, Rx only, For IV Use, NDC 61703-339-50 (Ho… by Hospira, citing crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-154-2013 |
| Classification | Class I |
| Status | completed |
| Initiated | 2012-11-08 |
| Published | 2013-02-13 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Hospira |
| Distribution | US |
Product
Carboplatin Injection, 450 mg/45 mL (10 mg/mL), 45 mL, Cytotoxic Agent, Sterile, Multi-Dose Vial, Rx only, For IV Use, NDC 61703-339-50 (Hospira label) and NDC 61703-360-50 (Novaplus label), Hospira, Inc., Lake Forest, IL 60045, Product of Australia.
Reason
Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals.
Identifiers
| ndc | 61703-339-18 |
|---|---|
| ndc | 61703-339-22 |
| ndc | 61703-339-50 |
| ndc | 61703-339-56 |
| ndc | 61703-360-50 |
| code_info | lots Z011711AA (Hospira label) and Z011711AB (Novaplus label), Exp. 08/2013 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-154-2013%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.