The Recall Desk
CriticalFDA (Drugs)·D-446-2015·Announced 2015-04-15

CAPS Recalls Compounded TPN Infusion Bags Due to Sterility Failure

Central Admixture Pharmacy Services is recalling four bags of compounded TPN infusion bags because they failed sterility tests for microbial contamination.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which is defined as a situation where use of or exposure to the product may cause serious adverse health consequences or death. The rubric mandates a score of 5 for FDA Class I recalls.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling four bags of compounded Total Parenteral Nutrition (TPN) infusion bags. The product, identified as Advocate Good Samaritan Hospital (IL) TPN Dextrose 10% Trophamine 2%, is a sterile injectable compounded drug packaged in 250 ml IV infusion bags. The specific lot number is 37-74662, with a manufacture date of December 15, 2014, and an expiration date of December 24, 2014.

The recall was initiated because the product failed sterility tests for microbial contamination, resulting in out-of-specification results. This indicates that the product may not be sterile as required for intravenous administration.

The affected product was distributed nationwide. Consumers and healthcare providers should stop using the recalled product immediately and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Advocate Good Samaritan Hospital (IL) TPN Dextrose 10% Trophamine 2%, Trophamine 2% Dextrose 10%, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown,
Affected units
4

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 (4)

  • lot number 37-74662 Made on 15 DEC 2014
  • EXP 24 DEC 2014
  • CAPS Rx: 37-74662-0-4-R
  • Disp ID: 37-1124593

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 34 recalled by Central Admixture Pharmacy Services, 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 34 products in this recall →