FDA Recalls Compounded Neonatal IV Infusion Bags Due to Sterility Failure
Central Admixture Pharmacy Services is recalling two bags of 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 agency classification is FDA Class I, which per the rubric mandates a score of 5 (Critical) regardless of other factors, as it indicates a reasonable probability that use of the product will cause serious adverse health consequences or death.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling two bags of Adventist Hinsdale Hospital (IL) Neonatal Starter IV infusion bags. The product is a compounded sterile injectable drug containing Troph 4% Dextrose 5%, Trophamine, and heparin, packaged in 250 ml IV infusion bags. The recall is limited to lot number 37-74764, which was made 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. The source text does not specify the type of microorganism or report any illnesses or injuries associated with the use of these specific bags.
The affected product was distributed nationwide. Consumers and healthcare providers should check their inventory for the specific lot number and contact the recalling firm or their healthcare provider for instructions on how to handle the product.
The recalled product
- Product
- Adventist Hinsdale Hospital (IL) Neonatal Starter: Troph 4%Dex5% ,Trophamine 4% Dextrose 5%, 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
- 2
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 37-74764
- Made on 15 DEC 2014
- EXP 24 DEC 2014
- CAPS Rx: 37-74764-0-2-R
- Disp ID: 37-1124734
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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