DOXOrubicin Hydrochloride Injection — Class III drug recall D-0105-2021
Terminated recall by Fresenius Kabi USA, LLC, reported 2020-12-02, distributed nationwide. Cross Contamination with Other Products: trace amounts of octreotide found during testing
| Recall number | D-0105-2021 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA, LLC, Lake Zurich, IL, United States |
| Recall initiated | 2020-11-17 |
| Classified | 2020-11-24 |
| Reported by FDA | 2020-12-02 |
| Terminated | 2022-08-25 |
| Distributed | Nationwide (US) |
| Quantity | 16,986 vials |
| NDC | 63323-0101, 63323-0101-61, 63323-0883, 63323-0883-05, 63323-0883-10, 63323-0883-30 |
| Lot numbers | 6120525 |
| Expiration dates | 2020-11 |
Product
DOXOrubicin Hydrochloride Injection, USP, 10 mg / 5 mL (2 mg / mL), 5 mL fill in a 6 mL vial, Single Dose Vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047. NDC: 63323-883-05
Reason for recall
Cross Contamination with Other Products: trace amounts of octreotide found during testing
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-0105-2021. 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.