Drug product
TPN 3:1, 1844 mL Bags, Qty: 6, Base Formula Sodium Chloride, Dextrose 70%, Clinisol SF 15%, Intralipid 20%, Water for Inj; Electrolytes KCL, Ca Gluconate, MgSO4, K Phos; Vitamins, trace elements and medications Multitrace-4, Multi Vitamin, 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-1165-2015
Product summary
- Firm
- Lincare, Inc.
- Event
- Event 71415
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6 Bags
- Official record key
drug-enforcement:D-1165-2015
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