The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1158-2015·Announced 2015-07-08

Lincare Recalls TPN 2:1 Bags Due to Sterility Concerns

Lincare, Inc. is recalling TPN 2:1 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, and the hazard involves a lack of assurance of sterility in an injectable medical product, which poses a significant risk of serious injury or death if contaminated.

Plain-English summary

Lincare, Inc. is recalling TPN 2:1, 200 ml bags (quantity of 7) that were 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 base formula, electrolytes, vitamins, trace elements, and medications.

The reason for the recall is a lack of assurance of sterility, meaning the sterility of the product is not assured. The distribution pattern includes the United States, specifically Arkansas.

Consumers and healthcare providers should stop using the affected product immediately and contact Lincare, Inc. or their healthcare provider for instructions on how to return the product or obtain a replacement.

The recalled product

Product
TPN 2:1, 200 ml Bags, Qty: 7, Base Formula NaCl 0.9%, Dextrose 70%, Trophamine 10%, Water for Inj; Electrolytes Calcium Gluc, MgSO4, Na Phos, KCL; Vitamins, trace elements and medications Copper Cl, Selenium, Zinc Sulfate, Infuvite Pediat, Rx Only. Compounded by: United Medical…
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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