The Recall Desk
CriticalFDA (Drugs)·D-447-2015·Announced 2015-04-15

Central Admixture Pharmacy Services Recalls Compounded TPN Bags Due to Sterility Failure

Central Admixture Pharmacy Services is recalling three bags of compounded TPN due to out-of-specification sterility test results indicating 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 corresponds to a Critical severity score per the rubric.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling three bags of compounded Total Parenteral Nutrition (TPN) products. The specific product is Methodist Hospital Northlake (IN) Neo Starter TPN D5, AA2, Trophamine 2% Dextrose 5%, with additives including heparin and calcium gluconate. The bags are sterile injectable, prescription-only, compounded drugs packaged in corrugated boxes with polystyrene inserts.

The recall was initiated because the product failed sterility tests for microbial contamination, resulting in out-of-specification results. This indicates a potential lack of sterility in the injectable solution.

The affected lot number is 37-74767, with a manufacture date of December 15, 2014, and an expiration date of December 24, 2014. The distribution pattern is listed as nationwide. Consumers and healthcare providers should discontinue use of the affected product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Methodist Hospital Northlake (IN) Neo Starter TPN D5, AA2, Trophamine 2% Dextrose 5%, Additives: heparin PF 100 units/mL, 50 units/dL, Calcium Gluconate 0.46 mEq/mL, 200 mg/dL, compound vol: 300 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corru
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 37-74767
  • Made on 15 DEC 2014
  • EXP 24 DEC 2014
  • CAPS Rx: 37-74767-0-3-R
  • Disp ID: 37-1124457

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 →