The Recall Desk
CriticalFDA (Drugs)·D-465-2015·Announced 2015-04-15

Central Admixture Pharmacy Services Recalls Non-Sterile TPN Infusion Bags

Central Admixture Pharmacy Services is recalling 3 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 agency classification is FDA Class I, which corresponds to a Critical severity score of 5 according to the rubric.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 3 bags of Bayshore Medical Center (TX) 10% Dextrose Starter Neo TPN, Trophamine 2.4%, Dextrose 10%, with additives heparin PF 1 unit(s)/ml and Calcium Gluconate 2.3mEq/dL. The product is a 250 ml sterile injectable compounded drug packaged in an IV infusion bag. The specific lot number is 37-74776, with a manufacture date of 15 DEC 2014 and an expiration date of 24 DEC 2014.

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

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

The recalled product

Product
Bayshore Medical Center (TX) 10% Dextrose Starter Neo TPN, Trophamine 2.4% , Dextrose 10%, Additives: heparin PF 1 unit(s)/ml, Calcium Gluconate 2.3mEq/dL, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each conta
Affected units
3

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 (5)

  • lot number 37-74776
  • Made on 15 DEC 2014
  • EXP 24 DEC 2014
  • CAPS Rx: 37-74776-0-3-R
  • Disp ID: 37-1124585

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 →