CARBOplatin Injection — Class II drug recall D-928-2013
Terminated recall by Teva Pharmaceuticals USA, Inc., reported 2013-09-11, distributed nationwide. Lack of Assurance of Sterility: The required reduction of endotoxin was not met during the annual revalidation
| Recall number | D-928-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Inc., Sellersville, PA, United States |
| Recall initiated | 2013-08-13 |
| Classified | 2013-09-03 |
| Reported by FDA | 2013-09-11 |
| Terminated | 2014-08-27 |
| Distributed | Nationwide (US) |
| Quantity | 780 vials |
| Reason classes | sterility |
| NDC | 00703-3249-11 |
| Lot numbers | 08/14, 10/14, 11/14, 31314458B, 31314459B, 31315794, 31315982B |
Product
CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618 NDC 0703-3249-11
Reason for recall
Lack of Assurance of Sterility: The required reduction of endotoxin was not met during the annual revalidation of the vial washer.
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-928-2013. 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.