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
D-200-2013
Product summary
- Event
- Event 64266
- Status
- Terminated
- Classification
- Class III
- Quantity
- 155,900 vials domestically
- Official record key
drug-enforcement:D-200-2013
Official wording
Reason: Labeling: Missing label
Code information: Lot 6004889, Expiration Date 10/2014
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Labeling: Missing