CALCIUM GLUCONATE INJECTION — Class III drug recall D-200-2013
Terminated recall by Fresenius Kabi USA LLC (FK USA), reported 2013-03-20, distributed nationwide. Labeling: Missing label
| Recall number | D-200-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA LLC (FK USA), Schaumburg, IL, United States |
| Recall initiated | 2013-02-01 |
| Classified | 2013-03-13 |
| Reported by FDA | 2013-03-20 |
| Terminated | 2013-11-18 |
| Distributed | Nationwide (US) |
| Quantity | 155,900 vials |
| Reason classes | labeling |
| NDC | 63323-0311-10 |
| Lot numbers | 6004889 |
| Expiration dates | 2014-10 |
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 for recall
Labeling: Missing label
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-200-2013. 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.