D-200-2013 Class III Terminated
FDA drug recall D-200-2013 was initiated by Fresenius Kabi USA LLC (FK USA) on February 1, 2013 and is designated Class III. Reason for recall: Labeling: Missing label The recall status is terminated (terminated November 18, 2013). Affected quantity: 155,900 vials domestically.
Recall Details
- Product Type
- Drugs
- Report Date
- March 20, 2013
- Initiation Date
- February 1, 2013
- Termination Date
- November 18, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 155,900 vials domestically
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
Reason for Recall
Labeling: Missing label
Distribution Pattern
Nationwide
Code Information
Lot 6004889, Expiration Date 10/2014