The Recall Desk
CriticalFDA (Drugs)·D-445-2015·Announced 2015-04-15

Central Admixture Pharmacy Services Recalls Compounded TPN Infusion Bags

Central Admixture Pharmacy Services is recalling 4 bags of compounded TPN infusion bags due to non-sterility test failures.

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 recall is classified as FDA Class I, which meets the criteria for a Critical severity score.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling four bags of compounded Total Parenteral Nutrition (TPN) infusion bags. The specific product is Advocate Good Samaritan Hospital (IL) TPN Dextrose 5% Trophamine 2%, Trophamine 5% Dextrose 2%, compound vol: 250 ml, sterile injectable, Rx only. The bags were packaged in corrugated boxes with polystyrene inserts.

The recall was initiated because the product failed sterility tests for microbial contamination. The affected lot number is 37-74661, with a manufacturing date of December 15, 2014, and an expiration date of December 24, 2014. The recall is classified as Class I by the FDA.

The distribution pattern is listed as nationwide. Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Advocate Good Samaritan Hospital (IL) TPN Dextrose 5% Trophamine 2%, Trophamine 5% Dextrose 2%, 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 37-74661 Made on 15 DEC 2014
  • EXP 24 DEC 2014
  • CAPS Rx: 37-74661-0-4-R
  • Disp ID: 37-1124589

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 →