Lincare Recalls TPN 3:1 Bags Due to Sterility Concerns
Lincare, Inc. is recalling TPN 3:1 bags compounded between May 14 and May 27, 2015, because the sterility of the product is not assured.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a significant risk of harm (lack of sterility in an IV product) corresponds to a severity score of 4 (Severe).
Plain-English summary
Lincare, Inc. is recalling TPN 3:1, 2250 mL bags (Quantity: 5) compounded by United Medical IV Center in Little Rock, Arkansas. The recall covers all product compounded between May 14, 2015, and May 27, 2015. The product is a prescription-only total parenteral nutrition formula containing dextrose, amino acids, lipids, electrolytes, vitamins, and trace elements.
The recall was initiated because the sterility of the product is not assured. This lack of assurance of sterility poses a potential risk of infection to patients receiving the intravenous therapy.
The affected product was distributed in the United States, including Arkansas. Patients and healthcare providers should stop using the recalled product and contact their healthcare provider or Lincare, Inc. for further instructions and replacement options.
The recalled product
- Product
- TPN 3:1, 2250 mL Bags, Qty: 5, Base Formula Sodium Chloride, Dextrose 70%, Clinisol SF 15%, Intralipid 20%, Water for Inj; Electrolytes KCL, K Phos, Famotidine, Na Acetate, MgSO4; Vitamins, trace elements and medications Multitrace-4, Multi Vitamin, Rx Only. Compounded by…
- Manufacturer
- Lincare, Inc.
- Category
- Drug — IV Therapy
- Affected units
- 5
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- All product compounded between May 14
- 2015 and May 27
- 2015
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 54 recalled by Lincare, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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