Class II · Moderate risk
Gentamicin Sulfate
Lack of Assurance of Sterility: Sterility of product is not assured.
Tpn 3:1
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Sterility of product is not assured.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
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.
- Recalling firm
- Lincare, Inc.
- Origin
- AR, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1165-2015 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Lincare, Inc.
All 2015 recalls
Class II · Moderate risk
Ganciclovir Sodium
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Fluorouracil 4250mg / D5W 285mL
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
HYDROmorphone HCl PF
Lack of Assurance of Sterility: Sterility of product is not assured.
Other sterility / contamination recalls from 2015
All sterility / contamination recalls
Class I · High risk
Human Chorionic Gonadotropin
Non-sterility: presence of mold confirmed by outside laboratory at the 14 day culture.
Class II · Moderate risk
Baclofen
Lack of assurance of sterility
Class II · Moderate risk
IT Custom Compound
Lack of Assurance of Sterility
Class II · Moderate risk
Baclofen 1 mg/ml in 40 ml NS syringe
Lack of Assurance of Sterility
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