The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1154-2015·Announced 2015-07-08

Lincare Recalls TPN 3:1 Bags Due to Sterility Concerns

Lincare, Inc. is recalling TPN 3:1 bags compounded by United Medical IV Center 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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in a parenteral nutrition product, which poses a significant risk of serious injury or death from infection, meeting the criteria for a Severe rating.

Plain-English summary

Lincare, Inc. is recalling TPN 3:1, 2000 mL bags (quantity: 7) that were compounded by United Medical IV Center in Little Rock, Arkansas. The recall is due to a lack of assurance of sterility, meaning the sterility of the product is not assured.

The affected product was compounded between May 14, 2015, and May 27, 2015. Distribution was limited to the United States, including Arkansas. The product is a prescription-only total parenteral nutrition solution containing dextrose, Travasol, Intralipid, sterile water, electrolytes, vitamins, trace elements, and medications.

Consumers and healthcare providers should stop using the recalled product and contact Lincare, Inc. or their healthcare provider for further instructions.

The recalled product

Product
TPN 3:1, 2000 mL Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Sterile Water; Electrolytes K Acetate, Na Acetate, Famotidine, Ca Gluconate, MgSO4, NaCl, Zinc Cl; Vitamins, trace elements and medications Salenium, Multi Vitamin, Vitamin K, Ascorbic Acid…
Manufacturer
Lincare, Inc.
Category
Drug — Total Parenteral Nutrition
Hazard
Affected units
7

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.

See all 54 products in this recall →

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