Fresenius Kabi USA LLC (FK USA) recalls CALCIUM GLUCONATE INJECTION, USP, 10% (100 mg/mL), 10 mL, Single Dose Vial, Rx only, For Direct Slow IV or IV Additive U
Recalled March 20, 2013 · FDA recall D-200-2013 · Fresenius Kabi USA LLC (FK USA)
Hazard
Labeling: Missing label · FDA Class III
Units
155,900 vials domestically
Sold at
Nationwide
Description
Labeling: Missing label
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
Manufacturer(s)
Fresenius Kabi USA LLC (FK USA)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →