US Drug Recall Register
Class III · Low risk Terminated Initiated Feb 1, 2013 (14 years ago)

CALCIUM GLUCONATE INJECTION, USP, 10% (100 mg/mL), 10 mL, Single Dose Vial, Rx only, For…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

Labeling: Missing label

What was recalled

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

Recalling firm
Fresenius Kabi USA LLC (FK USA)
NDC code
63323-311-10
Origin
IL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-200-2013

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.