Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility: Sterility of product is not assured.
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.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
Reason shortfill; reports of empty capsules.
Reason Presence of Particulate Matter: Hair was found in products
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
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