Daunorubicin Hydrochloride Injection — Class II drug recall D-392-2014
Terminated recall by Teva Pharmaceuticals USA, reported 2014-01-08, distributed nationwide. Presence of Precipitate; precipitation of drug product
| Recall number | D-392-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Horsham, PA, United States |
| Recall initiated | 2013-10-11 |
| Classified | 2013-12-30 |
| Reported by FDA | 2014-01-08 |
| Terminated | 2014-08-27 |
| Distributed | Nationwide (US) |
| Quantity | 13,520 vials |
| NDC | 00703-5233-11, 00703-5233-13, 00703-5233-91, 00703-5233-93 |
| Lot numbers | 31314801B, 31314990B, 31314991B, 31315014B, 31315155B, 31315279B, 31315837B, 31315921B, 31316029C, 31316029D |
Product
Daunorubicin Hydrochloride Injection, 20 mg/4 mL (5 mg/mL), 4 mL Single Dose Vial, Rx ONLY, For IV Use Only, Manufactured By: Teva parenteral Medicines, Inc., Irvine, CA NOVAPlus¿¿ labels. NDC 0703-5233-13 (carton), NDC 0703-5233-11 (vial) or NDC 0703-5233-93 (carton), NDC 0703-5233-91 (vial)
Reason for recall
Presence of Precipitate; precipitation of drug product
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-392-2014. 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.