CAPS Recalls Neonatal IV Infusion Bags Due to Sterility Failure
Central Admixture Pharmacy Services is recalling two bags of a neonatal IV infusion compound because sterility testing failed.
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 classified this as an FDA Class I recall, which meets the criteria for a Critical severity score.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling two bags of Robert Wood Johnson University (NJ) Neonatal Starter 5% Dextrose, Trophamine 5%, Dextrose 5% compound. The product is a sterile injectable IV infusion bag, 250 ml volume, packaged in a corrugated box with a polystyrene insert. The recall is limited to lot number 37-74634, which was made on December 15, 2014, and expires on December 24, 2014.
The recall was initiated because the product failed sterility testing for microbial contamination. The agency has classified this as a Class I recall. The distribution pattern is listed as nationwide.
Healthcare providers and patients should stop using the affected product immediately. Consumers should check their inventory for the specific lot number and contact their healthcare provider or the recalling firm for instructions on disposal or replacement.
The recalled product
- Product
- Robert Wood Johnson University (NJ) Neonatal Starter 5% Dextrose, Trophamine 5%, Dextrose 5%, 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 (5)
- lot number 37-74634
- Made on 15 DEC 2014
- EXP 24 DEC 2014
- CAPS Rx: 37-74634-0-2-R
- Disp ID: 37-1124681
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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