FDA Drug recall D-1148-2014
Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx only, NDC 63323-540…
- FDA Drug
- Class II
- terminated
- Published 2014-03-12
On 2014-03-12 the FDA classified a Class II recall of Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx only, NDC 63323-540… by Fresenius Kabi Usa, citing subpotent; 18 month time point.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1148-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-01-22 |
| Published | 2014-03-12 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Fresenius Kabi Usa |
| Distribution | US |
Product
Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx only, NDC 63323-540-11, 25 vials in tray, each boxed vial individually labeled as: Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx only, NDC 63323-540-11.
Reason
Subpotent; 18 month time point
Identifiers
| ndc | 63323-542-01 |
|---|---|
| ndc | 63323-542-07 |
| ndc | 63323-276-01 |
| ndc | 63323-276-02 |
| ndc | 63323-915-01 |
| ndc | 63323-047-01 |
| ndc | 63323-047-10 |
| ndc | 63323-543-02 |
| ndc | 63323-459-09 |
| ndc | 63323-540-01 |
| ndc | 63323-540-11 |
| ndc | 63323-540-31 |
| ndc | 63323-262-01 |
| code_info | Lot Number: 6004137, Expiration date: 06/2014 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1148-2014%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.