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

Recall Number: D-200-2013

Firm: Fresenius Kabi USA LLC (FK USA)

Classification: Class III

Status: Terminated

Report Date: 20130320

Initiation Date: 20130201

Termination Date: 20131118

Reason for Recall

Labeling: Missing label

Product Description

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