Magnesium Chloride Hexahydrate 82 — Class II drug recall D-0074-2020
Terminated recall by KRS Global Biotechnology, Inc, reported 2019-10-09, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0074-2020 |
|---|---|
| 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 | 2019-09-12 |
| Classified | 2019-10-01 |
| Reported by FDA | 2019-10-09 |
| Terminated | 2021-08-19 |
| Distributed | Nationwide (US) |
| Quantity | 878 vials |
| Reason classes | sterility |
Product
Magnesium Chloride Hexahydrate 82.5 mg/mL; Calcium Gluconate 30 mg/mL (PF), For IV Use, 10 mL Single Dose vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678355
Reason for recall
Lack of Assurance of Sterility
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-0074-2020. 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.