FDA Drug recall D-0105-2021
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…
- FDA Drug
- Class III
- terminated
- Published 2020-12-02
On 2020-12-02 the FDA classified a Class III recall of 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… by Fresenius Kabi Usa, citing cross Contamination with Other Products: trace amounts of octreotide found during testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0105-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2020-11-17 |
| Published | 2020-12-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Fresenius Kabi Usa |
| Distribution | US |
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
Cross Contamination with Other Products: trace amounts of octreotide found during testing
Identifiers
| ndc | 63323-883-05 |
|---|---|
| ndc | 63323-883-10 |
| ndc | 63323-883-30 |
| ndc | 63323-101-61 |
| code_info | Batch: 6120525, exp 11/2020 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0105-2021%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.