FDA Drug recall D-0951-2022
Calcium Gluconate Injection, USP 10%, 0.465 mEq Ca++/mL, 1 g/10 mL (100 mg/mL), 10 mL Pre-Filled Syringe, 5 x 10 Pre-filled Syringes, 6 x 5…
- FDA Drug
- Class II
- terminated
- Published 2022-06-08
On 2022-06-08 the FDA classified a Class II recall of Calcium Gluconate Injection, USP 10%, 0.465 mEq Ca++/mL, 1 g/10 mL (100 mg/mL), 10 mL Pre-Filled Syringe, 5 x 10 Pre-filled Syringes, 6 x 5… by Nephron Sterile Compounding Center, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0951-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-05-18 |
| Published | 2022-06-08 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Nephron Sterile Compounding Center |
| Distribution | US |
Product
Calcium Gluconate Injection, USP 10%, 0.465 mEq Ca++/mL, 1 g/10 mL (100 mg/mL), 10 mL Pre-Filled Syringe, 5 x 10 Pre-filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-950-10
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | Lots: CG1003A, Exp. 12/3/2022; CG2001A, Exp. 2/10/2023 |
|---|
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-0951-2022%22
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