FDA Drug recall D-0074-2020
Magnesium Chloride Hexahydrate 82.5 mg/mL
- FDA Drug
- Class II
- terminated
- Published 2019-10-09
On 2019-10-09 the FDA classified a Class II recall of Magnesium Chloride Hexahydrate 82.5 mg/mL by Krs Global Biotechnology, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0074-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-09-12 |
| Published | 2019-10-09 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Krs Global Biotechnology |
| Distribution | US |
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
Lack of Assurance of Sterility
Identifiers
| code_info | All lots remaining within expiry. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0074-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.