FDA Drug recall D-200-2013
CALCIUM GLUCONATE INJECTION, USP, 10% (100 mg/mL), 10 mL, Single Dose Vial, Rx only, For Direct Slow IV or IV Additive Use Only, APP Pharma…
- FDA Drug
- Class III
- terminated
- Published 2013-03-20
On 2013-03-20 the FDA classified a Class III recall of CALCIUM GLUCONATE INJECTION, USP, 10% (100 mg/mL), 10 mL, Single Dose Vial, Rx only, For Direct Slow IV or IV Additive Use Only, APP Pharma… by Fresenius Kabi Usa Fk Usa, citing labeling: Missing label.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-200-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-02-01 |
| Published | 2013-03-20 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Fresenius Kabi Usa Fk Usa |
| Distribution | US |
Product
CALCIUM GLUCONATE INJECTION, USP, 10% (100 mg/mL), 10 mL, Single Dose Vial, Rx only, For Direct Slow IV or IV Additive Use Only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 --- Product Code 31110, NDC 63323-311-10
Reason
Labeling: Missing label
Identifiers
| code_info | Lot 6004889, Expiration Date 10/2014 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-200-2013%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.