Drug product
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.
D-1158-2015
Product summary
- Firm
- Lincare, Inc.
- Event
- Event 71415
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7 Bags
- Official record key
drug-enforcement:D-1158-2015
Official wording
Reason: Lack of Assurance of Sterility: Sterility of product is not assured.
Code information: All product compounded between May 14, 2015 and May 27, 2015
Distribution pattern: United States including: Arkansas
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility