CITRULLINE — Class I drug recall D-0674-2016
Terminated recall by Medisca Inc, reported 2016-02-24, distributed nationwide. Labeling: Label Mix-Up: FDA tested samples of API from Medisca, labeled as to contain L-Citrulline, and result
| Recall number | D-0674-2016 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medisca Inc, Plattsburgh, NY, United States |
| Recall initiated | 2014-02-14 |
| Classified | 2016-02-17 |
| Reported by FDA | 2016-02-24 |
| Terminated | 2016-02-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU |
| Reason classes | labeling |
| NDC | 38779-1186-04, 38779-1186-05, 38779-1186-08, 38779-1186-09 |
| Lot numbers | 95482/A, 95482/B, 95482/C, 95482/D, 96453/A, 96453/B, 96453/C, 96453/D |
| Expiration dates | 2014-10-31 |
Product
CITRULLINE (L) in 25 g, 100 g, 500 g and 1 kg plastic bottles, White crystals or crystalline powder, odorless, For Use and distribution in prescription compounding, manufacturing, processing, or repackaging only in accordance with FDA regulations and applicable law, Packaged by Medisca Inc. Plattsburgh, NY 12901, USA, NDC #s: 38779-1186-4 (25 g), 38779-1186-5 (100 g), 38779-1186-8 (500 g), 38779-1186-9 (1 kg).
Reason for recall
Labeling: Label Mix-Up: FDA tested samples of API from Medisca, labeled as to contain L-Citrulline, and results revealed no L-Citrulline was present. Levels of N-acetyl-leucine were found instead.
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-0674-2016. 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.