Parenteral Amino Acid Infusion 10% — Class II drug recall D-0614-2016
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-0614-2016 |
|---|---|
| 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
Parenteral Amino Acid Infusion 10%, Packaged in a) 780ML Homepumps, b) 1000ML Homepumps, c) 1140ML Homepumps, d) 1152ML Homepumps, e) 1400ML Homepumps, f) 1440ML Homepumps, g) 1500ML Homepumps, h) 1700ML Homepumps, i) 1900ML Homepumps, j) 2130ML Homepumps, k) 2250ML Homepumps, l) 2400ML Homepumps, m) 2650ML Homepumps, n) 2700ML Homepumps, o) 3250ML Homepumps, p) 3390ML Homepumps, and q) 3500ML 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-0614-2016. 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.