The Recall Desk
CriticalFDA (Drugs)·D-462-2015·Announced 2015-04-15

Central Admixture Pharmacy Services Recalls TPN Neonatal Starter Bags

Central Admixture Pharmacy Services is recalling TPN Neonatal Starter IV infusion bags due to out-of-specification sterility test results.

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 mandates a severity score of 5 according to the rubric.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling TPN Neonatal Starter 0.4-0.599 Kg IV infusion bags. The product is a compounded drug containing amino acids, dextrose, heparin, and calcium gluconate, packaged in 150 ml sterile injectable bags. The recall is limited to lot number 37-74653, which was made on December 15, 2014, and has 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 a potential risk of non-sterility in the affected bags.

The affected product was distributed nationwide. Healthcare providers and patients who have used or possess this specific lot should contact their healthcare provider or the recalling firm for further instructions on how to proceed.

The recalled product

Product
Abington Memorial Hospital (PA) TPN Neonatal Starter 0.4-0.599 Kg, Amino Acids, Neonate 3g, Dextrose 5%, 150 ml, Additives: heparin PF 75 units, Calcium Gluconate 300mg, compound vol: 150 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated
Affected units
1

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 37-74653
  • Made on 15 DEC 2014
  • EXP 24 DEC 2014
  • CAPS Rx: 37-74653-0-1-R
  • Disp ID: 37-1124735

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 →