CAPS Recalls Neonate Starter IV Infusion Bags Due to Sterility Failure
Central Admixture Pharmacy Services is recalling two bags of Neonate Starter 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 classified this recall as Class I, which corresponds to a Critical severity score under the rubric.
Plain-English summary
Central Admixture Pharmacy Services, Inc. (CAPS) is recalling two bags of The Medical Center of Aurora (CO) Neonate Starter 2% AA/D10W, Trophamine 2% Dextrose 10% IV infusion bags. The product is a sterile injectable compounded drug packaged in 250 ml bags.
The recall was initiated because the product failed out-of-specification results for the sterility test, indicating microbial contamination. The affected lot number is 37-74705, with a manufacture date of December 15, 2014, and an expiration date of December 24, 2014.
The product was distributed nationwide. Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- The Medical Center of Aurora (CO) Neonate Starter 2% AA/D10W, Trophamine 2% Dextrose 10%, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — 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 (6)
- Neonate Starter 2% AA/D10W
- lot number 37-74705
- Made on 15 DEC 2014
- EXP 24 DEC 2014
- CAPS Rx: 37-74705-0-2-R
- Disp ID: 37-1124595
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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