Carboplatin Injection — Class I drug recall D-154-2013
Completed recall by Hospira Inc., reported 2013-02-13, distributed nationwide. Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspe
| Recall number | D-154-2013 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2012-11-08 |
| Classified | 2013-02-06 |
| Reported by FDA | 2013-02-13 |
| Terminated | 2017-03-20 |
| Distributed | Nationwide (US) |
| Quantity | 31,326 vials |
| Reason classes | specification failure |
| NDC | 61703-0339, 61703-0339-18, 61703-0339-22, 61703-0339-50, 61703-0339-56, 61703-0360-50 |
| Lot numbers | Z011711AA |
| Expiration dates | 2013-08 |
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 for recall
Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals.
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-154-2013. 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.