FDA Recalls Compounded Neonatal IV Infusion Bags Due to Sterility Failure
Central Admixture Pharmacy Services is recalling compounded neonatal IV infusion bags because they failed sterility tests for microbial contamination.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly identifies this as an FDA Class I recall, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling a specific lot of compounded neonatal IV infusion bags. The product, identified as Adventist Hinsdale Hospital (IL) Neonatal Starter, is a sterile injectable solution containing Troph 2% Dex10%, Trophamine 2% Dextrose 10%, and heparin. The recall is limited to lot number 37-74765, which was manufactured on December 15, 2014, and has an expiration date of December 24, 2014.
The recall was initiated because the product failed out-of-specification results for the sterility test, indicating microbial contamination. This is a Class I recall, which the FDA classifies as the most serious type of recall where there is a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death.
Healthcare facilities and patients who may have received this specific lot of IV infusion bags should contact their healthcare provider or the recalling firm for further instructions. Consumers should not use the product if they have it in their possession.
The recalled product
- Product
- Adventist Hinsdale Hospital (IL) Neonatal Starter: Troph 2% Dex10%, Trophamine 2% Dextrose 10%, Additives: heparin PF 0.5 unit(s)/ml, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a…
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Compounded IV Infusion
- 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 37-74765
- Made on 15 DEC 2014
- EXP 24 DEC 2014
- CAPS Rx: 37-74765-0-1-R
- Disp ID: 37-1124732
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.
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