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

FDA recall notice · announced March 20, 2013 · Fresenius Kabi Usa Llc (fk Usa)

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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

Notes

Distribution: Nationwide
Lot/code information: Lot 6004889, Expiration Date 10/2014
Quantity: 155,900 vials domestically
Status: Terminated
Products in this recall event:
- 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, N (D-200-2013)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.