CLASS III Drug recall · Reported 20 Mar 2013 · FDA Enforcement Report
Calcium Gluconate Injection, USP, 10% (100 mg/mL), Single Dose Vial recalled
Fresenius Kabi USA LLC (FK USA) is recalling Calcium Gluconate Injection, USP, 10% (100 mg/mL), Single Dose Vial, distributed nationwide in the US. The recall was initiated on 1 Feb 2013 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-200-2013
- FDA event ID
- 64266
- Recalling firm
- Fresenius Kabi USA LLC (FK USA), Schaumburg, IL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 1 Feb 2013
- FDA classified
- 13 Mar 2013
- Reported
- 20 Mar 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Drug class
- Injectable & IV Drugs
Timeline
| 1 Feb 2013 | Recall initiated by company | |
| 13 Mar 2013 | Classified by FDA | +40 days |
| 20 Mar 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Missing label
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Labeling: Missing label
Which lots are affected?
Lot 6004889, Expiration Date 10/2014
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Fresenius Kabi USA LLC (FK USA)
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Irinotecan Hydrochloride Injection, 40 mg recalled | Fresenius Kabi USA LLC (FK USA) | Other | Nationwide |
Other Calcium Gluconate recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Calcium Gluconate Injection, USP 10%, 0.465 mEq Ca++/mL recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | Calcium Gluconate 10%, 100 mg/mL Injectable recalled | Pharm D Solutions | Sterility | Nationwide |
| Drug | CLASS II | Calcium Gluconate injectable, 10% Single Dose vial recalled | Auro Pharmacies | Sterility | Nationwide |
| Drug | CLASS II | Calcium Gluconate 10% Injection recalled by Tri-Coast Pharmacy | Tri-Coast Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Calcium Gluconate 10% Injection, Rx recalled by Western Drug | Western Drug | Sterility | Nationwide |