FDA recall D-200-2013

Fresenius Kabi USA LLC (FK USA) · Class III · drug

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

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2013-02-01
Report date: 2013-03-20
Termination date: 2013-11-18
Voluntary/Mandated: Voluntary: Firm initiated
Location: Schaumburg, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-200-2013