Status
Terminated
Drug Enforcement D-200-2013
Labeling: Missing label
Classification
Class III
Report Date
March 20, 2013
Termination Date
November 18, 2013
Product Information
- 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
- Product quantity
- 155,900 vials domestically
- Reason for recall
- Labeling: Missing label
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Fresenius Kabi USA LLC (FK USA)
- Address
-
1501 E Woodfield Rd, Suite 300 East
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-200-2013
- Event ID
- 64266
- Recall initiation date
- February 1, 2013
- Center classification date
- March 13, 2013
- Code info
- Lot 6004889, Expiration Date 10/2014
- More code info
- —