CLASS II Drug recall · Reported 8 Jul 2015 · FDA Enforcement Report
TPN 3:1 with lipids, Qty: 7, Base Formula Dextrose recalled by Lincare
Lincare is recalling TPN 3:1 with lipids, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, distributed in Arkansas. The recall was initiated on 28 May 2015 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1155-2015
- FDA event ID
- 71415
- Recalling firm
- Lincare, Little Rock, AR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 May 2015
- FDA classified
- 1 Jul 2015
- Reported
- 8 Jul 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 28 May 2015 | Recall initiated by company | |
| 1 Jul 2015 | Classified by FDA | +34 days |
| 8 Jul 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: Sterility of product is not assured.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
TPN 3:1, 997 ml with lipids Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Water for Inj; Electrolytes K Acetate, Na Acetate, KCL, Na Phos, Ca Gluconate, MgSO4, NaCl, Zinc Cl; Vitamins, trace elements and medications Selenium, Copper Cl, Carnitor, Rx Only. United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900.
Where it was distributed
United States including: Arkansas
Questions about this recall
Is TPN 3:1 with lipids, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20% recalled?
Yes. Lincare recalled TPN 3:1 with lipids, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20% on 28 May 2015. The recall is Class II and its status is Terminated. Recall number D-1155-2015.
Why was it recalled?
Lack of Assurance of Sterility: Sterility of product is not assured.
Which lots are affected?
All product compounded between May 14, 2015 and May 27, 2015
Where was it sold?
United States including: Arkansas
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Lincare
All 54| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Fluorouracil 4250mg / D5W, Qty recalled by Lincare | Lincare | Sterility | AR |
| Drug | CLASS II | TPN 3:1, Qty: 2, Base Formula NaCl 9%, Dextrose recalled by Lincare | Lincare | Sterility | AR |
| Drug | CLASS II | Fluorouracil 4600mg / D5W, Qty recalled by Lincare | Lincare | Sterility | AR |
| Drug | CLASS II | Vancomycin HCL 250mg / NS syringe recalled by Lincare | Lincare | Sterility | AR |
| Drug | CLASS II | Cefepime 1gm / NS AccuFlo recalled by Lincare | Lincare | Sterility | AR |