Heparin Sodium Injection — Class II drug recall D-1148-2014
Terminated recall by Fresenius Kabi USA, LLC, reported 2014-03-12, distributed nationwide. Subpotent; 18 month time point
| Recall number | D-1148-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA, LLC, Grand Island, NY, United States |
| Recall initiated | 2014-01-22 |
| Classified | 2014-03-05 |
| Reported by FDA | 2014-03-12 |
| Terminated | 2016-05-24 |
| Distributed | Nationwide (US) |
| Quantity | 161,650 vials |
| Reason classes | potency |
| NDC | 63323-0047, 63323-0047-01, 63323-0047-10, 63323-0262, 63323-0262-01, 63323-0276, 63323-0276-01, 63323-0276-02, 63323-0459, 63323-0459-09, 63323-0540, 63323-0540-01, 63323-0540-11, 63323-0540-31, 63323-0542, 63323-0542-01, 63323-0542-07, 63323-0543, 63323-0543-02, 63323-0915, 63323-0915-01 |
| Lot numbers | 6004137 |
| Expiration dates | 2014-06 |
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 for recall
Subpotent; 18 month time point
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-1148-2014. 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.