INTRALIPID — Class II drug recall D-0618-2016
Terminated recall by Sentara Enterprises, reported 2016-02-03, distributed in NC, VA. Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
| Recall number | D-0618-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sentara Enterprises, Chesapeake, VA, United States |
| Recall initiated | 2015-09-18 |
| Classified | 2016-01-28 |
| Reported by FDA | 2016-02-03 |
| Terminated | 2016-06-29 |
| Distributed | NC, VA |
| Reason classes | sterility |
Product
INTRALIPID (fat emulsion), Packaged in a) 27ML Homepumps, b) 125ML Homepumps, c) 1800ML Homepumps, d) 2000ML Homepumps e) 2350ML Homepumps, and f) 2800ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Reason for recall
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
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-0618-2016. 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.