FDA-Drug2013-03-20Class III
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
Fresenius Kabi USA LLC (FK USA)
Hazard
Labeling: Missing label
Sold states
Nationwide
Affected count
155,900 vials domestically
Manufactured in
1501 E Woodfield Rd, Suite 300 East, Schaumburg, IL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-200-2013Don't want to check this manually?
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