NORepinephrine 16 mg added to 0 — Class II drug recall D-1078-2019
Terminated recall by KRS Global Biotechnology, Inc, reported 2019-04-10, distributed nationwide. Labeling: Label mix-up
| Recall number | D-1078-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | KRS Global Biotechnology, Inc, Boca Raton, FL, United States |
| Recall initiated | 2019-01-16 |
| Classified | 2019-04-04 |
| Reported by FDA | 2019-04-10 |
| Terminated | 2021-02-04 |
| Distributed | Nationwide (US) |
| Quantity | 190 |
| Reason classes | labeling |
| Expiration dates | 2019-01-25 |
Product
NORepinephrine 16 mg added to 0.9% Sodium Chloride (PF), 16 mg / 250 mL, 250 mL IV bag, Rx only, KRS Global Biotechnology: 791 Park of Commerce Blvd., Boca Raton, FL 33487. NDC 3321678343
Reason for recall
Labeling: Label mix-up
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-1078-2019. 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.