D-1158-2015 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 8, 2015
- Initiation Date
- May 28, 2015
- Termination Date
- February 16, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 Bags
Product Description
TPN 2:1, 200 ml Bags, Qty: 7, Base Formula NaCl 0.9%, Dextrose 70%, Trophamine 10%, Water for Inj; Electrolytes Calcium Gluc, MgSO4, Na Phos, KCL; Vitamins, trace elements and medications Copper Cl, Selenium, Zinc Sulfate, Infuvite Pediat, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900.
Reason for Recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Distribution Pattern
United States including: Arkansas
Code Information
All product compounded between May 14, 2015 and May 27, 2015